麻醉学器械

医疗器械中英文对照－－麻醉学器械 (Anesthesiology Devices)

（《联邦规章典集》第21篇第868部[21CFR868]）

目录

节号 中译文 原英文 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 V olume 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

868.2300 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