Anesthesiology Devices麻醉学医疗器械中英文对照.doc
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Anesthesiology Devices麻醉学医疗器械中英文对照
A亚部――总则(General Provisions)
868.1
范围
Scope
868.3
有关上市前批准生效日期的要求
Effective dates of requirement for premarket approval
868.9
联邦食品、药品和化妆品法(Federal Food, Drug, and Cosmetic Act，FDCA)第510(k)节的豁免限制
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
B亚部――诊断器械(Diagnostic Devices)
868.1030
手动痛觉计
Manual algesimeter
868.1640
电动痛觉计
Powered algesimeter
868.1075
氩气分析仪
Argon gas analyzer
868.1100
动脉血取样工具箱
Arterial blood sampling kit
868.1120
心内血氧基血红素浓度分析仪
Indwelling blood oxyhemoglobin concentration analyzer
868.1150
心内血二氧化碳分压 (PCO2) 分析仪
Indwelling blood carbon dioxide partial pressure (PCO2) analyzer
868.1170
心内血氢离子浓度 (pH) 分析仪
Indwelling blood hydrogen ion concentration (pH) analyzer
868.1200
心内血氧分压 (PO2) 分析仪
Indwelling blood oxygen partial pressure (PO2) analyzer
868.1400
二氧化碳气体分析仪
Carbon dioxide gas analyzer
868.1430
一氧化碳气体分析仪
Carbon monoxide gas analyzer
868.1500
安氟醚气体分析仪
Enflurane gas analyzer
868.1575
气体收集容器
Gas collection vessel
868.1620
氟烷气体分析仪
Halothane gas analyzer
868.1640
氦气分析仪
Helium gas analyzer
868.1670
氖气分析仪
Neon gas analyzer
868.1690
氮气分析仪
Nitrogen gas analyzer
868.1700
一氧化二氮气体分析仪
Nitrous oxide gas analyzer
868.1720
氧气分析仪
Oxygen gas analyzer
868.1730
耗氧量计算机
Oxygen uptake computer
868.1750
压力体积描记器
Pressure plethysmograph
868.1760
容量描记器
Volume plethysmograph
868.1780
吸气呼吸道压力计
Inspiratory airway pressure meter
868.1800
鼻气流计
Rhinoanemometer
868.1840
诊断用肺活量计
Diagnostic spirometer
868.1850
监测用肺活量计
Monitoring spirometer
868.1860
肺活量测定用最大气流量计
Peak-flow meter for spirometry
868.1870
气体容积定标器
Gas volume calibrator
868.1880
肺功能数据计算器
Pulmonary-function data calculator
868.1890
预测用肺功能值计算器
Predictive pulmonary-function value calculator
868.1900
诊断用肺功能说明计算器
Diagnostic pulmonary-function interpretation calculator
868.1910
食道听诊器
Esophageal stethoscope
868.1920
电导体式食道听诊器
Esophageal stethoscope with electrical conductors
868.1930
听诊器头
Stethoscope head
868.1965
转换阀
Switching valve (ploss)
868.1975
水蒸气分析仪
Water vapor analyzer
C亚部――监测装置(Monitoring Devices)
868.2025
超声空气栓子监测器
Ultrasonic air embolism monitor
波登表流量计
Bourdon gauge flowmeter
868.2320
非补偿式thorpe管流量计
Uncompensated thorpe tube flowmeter
868.2340
补偿式thorpe管流量计
Compensated thorpe tube flowmeter
868.2350
气体校准流量计
Gas calibration flowmeter
868.2375
呼吸频率监测器
Breathing frequency monitor
868.2377
呼吸暂停监测器
Apnea monitor
868.2380
氧化氮分析仪
Nitric oxide analyzer
868.2385
二氧化氮分析仪
Nitrogen dioxide analyzer
868.2450
肺水监测器
Lung water monitor
868.2480
皮肤二氧化碳 (PcCO2) 监测器
Cutaneous carbon dioxide (PcCO2) monitor
868.2500
皮肤氧气 (PcO2) 监测器
Cutaneous oxygen (PcO2) monitor
868.2550
呼吸流速计
Pneumotachometer
868.2600
呼吸道压力监测器
Airway pressure monitor
868.2610
气体压力计
Gas pressure gauge
868.2620
气体压力定标器
Gas pressure calibrator
868.2700
压力调节器
Pressure regulator
868.2775
末梢神经电动刺激仪
Electrical peripheral nerve stimulator
868.2875
压差传感器
Differential pressure transducer
868.2885
气流传感器
Gas flow transducer
868.2900
气压传感器
Gas pressure transducer
D-E亚部 [保留] (Reserved)
F亚部 ――治疗设备(Therapeutic Devices)
868.5090
紧急呼吸道针
Emergency airway needle
868.5100
鼻咽导气管
Nasopharyngeal airway
868.5110
口咽导气管
Oropharyngeal airway
868.5115
减轻急性上呼吸道梗塞用设备
Device to relieve acute upper airway obstruction
868.5120
麻醉引流导管
Anesthesia conduction catheter
868.5130
麻醉引流过滤器
Anesthesia conduction filter
868.5140
麻醉引流工具箱
Anesthesia conduction kit
868.5150
麻醉引流针
Anesthesia conduction needle
868.5160
麻醉或痛觉丧失用气体麻醉机
Gas machine for anesthesia or analgesia
868.5165
氧化氮给药装置
Nitric oxide administration apparatus
868.5170
喉气管局部麻醉涂药器
Laryngotracheal topical anesthesia applicator
868.5180
摇床
Rocking bed
868.5220
吹气瓶
Blow bottle
868.5240
麻醉呼吸管路
Anesthesia breathing circuit
868.5250
呼吸管路循环器
Breathing circuit circulator
868.5260
呼吸管路细菌过滤器
Breathing circuit bacterial filter
868.5270
呼吸系统加热器
Breathing system heater
868.5280
呼吸管支撑物
Breathing tube support
868.5300
二氧化碳吸收剂
Carbon dioxide absorbent
868.5310
二氧化碳吸收体
Carbon dioxide absorber
868.5320
储气袋
Reservoir bag
868.5330
呼吸气体混合器
Breathing gas mixer
868.5340
鼻氧套管
Nasal oxygen cannula
868.5350
鼻氧导管
Nasal oxygen catheter
868.5365
心脏或肺部治疗用体位椅
Posture chair for cardiac or pulmonary treatment
868.5375
加热和湿气冷凝器 (人造鼻)
Heat and moisture condenser (artificial nose)
868.5400
电麻醉装置
Electroanesthesia apparatus
868.5420
乙醚钩
Ether hook
868.5430
气体净化装置
Gas-scavenging apparatus
868.5440
便携式氧发生器
Portable oxygen generator
868.5450
呼吸气体增湿器
Respiratory gas humidifier
868.5460
家用治疗增湿器
Therapeutic humidifier for home use
868.5470
高压舱
Hyperbaric chamber
868.5530
柔韧性喉镜
Flexible laryngoscope
868.5540
刚性喉镜
Rigid laryngoscope
868.5550......（后略) ......
Anesthesiology Devices麻醉学医疗器械中英文对照
A亚部――总则(General Provisions)
868.1
范围
Scope
868.3
有关上市前批准生效日期的要求
Effective dates of requirement for premarket approval
868.9
联邦食品、药品和化妆品法(Federal Food, Drug, and Cosmetic Act，FDCA)第510(k)节的豁免限制
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
B亚部――诊断器械(Diagnostic Devices)
868.1030
手动痛觉计
Manual algesimeter
868.1640
电动痛觉计
Powered algesimeter
868.1075
氩气分析仪
Argon gas analyzer
868.1100
动脉血取样工具箱
Arterial blood sampling kit
868.1120
心内血氧基血红素浓度分析仪
Indwelling blood oxyhemoglobin concentration analyzer
868.1150
心内血二氧化碳分压 (PCO2) 分析仪
Indwelling blood carbon dioxide partial pressure (PCO2) analyzer
868.1170
心内血氢离子浓度 (pH) 分析仪
Indwelling blood hydrogen ion concentration (pH) analyzer
868.1200
心内血氧分压 (PO2) 分析仪
Indwelling blood oxygen partial pressure (PO2) analyzer
868.1400
二氧化碳气体分析仪
Carbon dioxide gas analyzer
868.1430
一氧化碳气体分析仪
Carbon monoxide gas analyzer
868.1500
安氟醚气体分析仪
Enflurane gas analyzer
868.1575
气体收集容器
Gas collection vessel
868.1620
氟烷气体分析仪
Halothane gas analyzer
868.1640
氦气分析仪
Helium gas analyzer
868.1670
氖气分析仪
Neon gas analyzer
868.1690
氮气分析仪
Nitrogen gas analyzer
868.1700
一氧化二氮气体分析仪
Nitrous oxide gas analyzer
868.1720
氧气分析仪
Oxygen gas analyzer
868.1730
耗氧量计算机
Oxygen uptake computer
868.1750
压力体积描记器
Pressure plethysmograph
868.1760
容量描记器
Volume plethysmograph
868.1780
吸气呼吸道压力计
Inspiratory airway pressure meter
868.1800
鼻气流计
Rhinoanemometer
868.1840
诊断用肺活量计
Diagnostic spirometer
868.1850
监测用肺活量计
Monitoring spirometer
868.1860
肺活量测定用最大气流量计
Peak-flow meter for spirometry
868.1870
气体容积定标器
Gas volume calibrator
868.1880
肺功能数据计算器
Pulmonary-function data calculator
868.1890
预测用肺功能值计算器
Predictive pulmonary-function value calculator
868.1900
诊断用肺功能说明计算器
Diagnostic pulmonary-function interpretation calculator
868.1910
食道听诊器
Esophageal stethoscope
868.1920
电导体式食道听诊器
Esophageal stethoscope with electrical conductors
868.1930
听诊器头
Stethoscope head
868.1965
转换阀
Switching valve (ploss)
868.1975
水蒸气分析仪
Water vapor analyzer
C亚部――监测装置(Monitoring Devices)
868.2025
超声空气栓子监测器
Ultrasonic air embolism monitor
波登表流量计
Bourdon gauge flowmeter
868.2320
非补偿式thorpe管流量计
Uncompensated thorpe tube flowmeter
868.2340
补偿式thorpe管流量计
Compensated thorpe tube flowmeter
868.2350
气体校准流量计
Gas calibration flowmeter
868.2375
呼吸频率监测器
Breathing frequency monitor
868.2377
呼吸暂停监测器
Apnea monitor
868.2380
氧化氮分析仪
Nitric oxide analyzer
868.2385
二氧化氮分析仪
Nitrogen dioxide analyzer
868.2450
肺水监测器
Lung water monitor
868.2480
皮肤二氧化碳 (PcCO2) 监测器
Cutaneous carbon dioxide (PcCO2) monitor
868.2500
皮肤氧气 (PcO2) 监测器
Cutaneous oxygen (PcO2) monitor
868.2550
呼吸流速计
Pneumotachometer
868.2600
呼吸道压力监测器
Airway pressure monitor
868.2610
气体压力计
Gas pressure gauge
868.2620
气体压力定标器
Gas pressure calibrator
868.2700
压力调节器
Pressure regulator
868.2775
末梢神经电动刺激仪
Electrical peripheral nerve stimulator
868.2875
压差传感器
Differential pressure transducer
868.2885
气流传感器
Gas flow transducer
868.2900
气压传感器
Gas pressure transducer
D-E亚部 [保留] (Reserved)
F亚部 ――治疗设备(Therapeutic Devices)
868.5090
紧急呼吸道针
Emergency airway needle
868.5100
鼻咽导气管
Nasopharyngeal airway
868.5110
口咽导气管
Oropharyngeal airway
868.5115
减轻急性上呼吸道梗塞用设备
Device to relieve acute upper airway obstruction
868.5120
麻醉引流导管
Anesthesia conduction catheter
868.5130
麻醉引流过滤器
Anesthesia conduction filter
868.5140
麻醉引流工具箱
Anesthesia conduction kit
868.5150
麻醉引流针
Anesthesia conduction needle
868.5160
麻醉或痛觉丧失用气体麻醉机
Gas machine for anesthesia or analgesia
868.5165
氧化氮给药装置
Nitric oxide administration apparatus
868.5170
喉气管局部麻醉涂药器
Laryngotracheal topical anesthesia applicator
868.5180
摇床
Rocking bed
868.5220
吹气瓶
Blow bottle
868.5240
麻醉呼吸管路
Anesthesia breathing circuit
868.5250
呼吸管路循环器
Breathing circuit circulator
868.5260
呼吸管路细菌过滤器
Breathing circuit bacterial filter
868.5270
呼吸系统加热器
Breathing system heater
868.5280
呼吸管支撑物
Breathing tube support
868.5300
二氧化碳吸收剂
Carbon dioxide absorbent
868.5310
二氧化碳吸收体
Carbon dioxide absorber
868.5320
储气袋
Reservoir bag
868.5330
呼吸气体混合器
Breathing gas mixer
868.5340
鼻氧套管
Nasal oxygen cannula
868.5350
鼻氧导管
Nasal oxygen catheter
868.5365
心脏或肺部治疗用体位椅
Posture chair for cardiac or pulmonary treatment
868.5375
加热和湿气冷凝器 (人造鼻)
Heat and moisture condenser (artificial nose)
868.5400
电麻醉装置
Electroanesthesia apparatus
868.5420
乙醚钩
Ether hook
868.5430
气体净化装置
Gas-scavenging apparatus
868.5440
便携式氧发生器
Portable oxygen generator
868.5450
呼吸气体增湿器
Respiratory gas humidifier
868.5460
家用治疗增湿器
Therapeutic humidifier for home use
868.5470
高压舱
Hyperbaric chamber
868.5530
柔韧性喉镜
Flexible laryngoscope
868.5540
刚性喉镜
Rigid laryngoscope
868.5550......（后略) ......