| 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 |
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 |
| 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 |
| 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 |
麻醉剂防毒面罩 |
Anesthetic gas mask |
| 868.5560 |
防毒面罩头带 |
Gas mask head strap |
| 868.5570 |
非再呼吸性面罩 |
Nonrebreathing mask |
| 868.5580 |
氧气面罩 |
Oxygen mask |
| 868.5590 |
换气面罩 |
Scavenging mask |
| 868.5600 |
文氏管面罩 |
Venturi mask |
| 868.5610 |
长期肺部支持用的膜式肺 |
Membrane lung for long-term pulmonary support |
| 868.5620 |
呼吸吹口 |
Breathing mouthpiece |
| 868.5630 |
喷雾器 |
Nebulizer |
| 868.5640 |
药用非换气式喷雾器 （雾化器） |
Medicinal nonventilatory nebulizer （atomizer） |
| 868.5650 |
食道闭塞器 |
Esophageal obturator |
| 868.5655 |
便携式液氧装置 |
Portable liquid oxygen unit |
| 868.5665 |
动力叩诊器 |
Powered percussor |
| 868.5675 |
再呼吸设备 |
Rebreathing device |
| 868.5690 |
刺激用肺活量计 |
Incentive spirometer |
| 868.5700 |
非动力氧气帐 |
Nonpowered oxygen tent |
| 868.5710 |
电动氧气帐 |
Electrically powered oxygen tent |
| 868.5720 |
支气管套管 |
Bronchial tube |
| 868.5730 |
气管套管 |
Tracheal tube |
| 868.5740 |
气管/支气管差异性换气管 |
Tracheal/bronchial differential ventilation tube |
| 868.5750 |
充气式气管套管袖带 |
Inflatable tracheal tube cuff |
| 868.5760 |
袖带涂铺器 |
Cuff spreader |
| 868.5770 |
气管套管固定装置 |
Tracheal tube fixation device |
| 868.5780 |
套管导入镊子 |
Tube introduction forceps |
| 868.5790 |
气管套管探针 |
Tracheal tube stylet |
| 868.5795 |
气管套管清洁刷 |
Tracheal tube cleaning brush |
| 868.5800 |
气管切开插管和套管袖带 |
Tracheostomy tube and tube cuff |
| 868.5810 |
导气管连接器 |
Airway connector |
| 868.5820 |
牙齿保护器 |
Dental protector |
| 868.5830 |
自体输血装置 |
Autotransfusion apparatus |
| 868.5860 |
压力管道系统和附件 |
Pressure tubing and accessories |
| 868.5870 |
非再呼吸阀 |
Nonrebreathing valve |
| 868.5880 |
麻醉剂蒸发器 |
Anesthetic vaporizer |
| 868.5895 |
连续式呼吸器 |
Continuous ventilator |
| 868.5905 |
非连续式呼吸器 （IPPB） |
Noncontinuous ventilator （IPPB） |
| 868.5915 |
手动急救呼吸器 |
Manual emergency ventilator |
| 868.5925 |
电动急救呼吸器 |
Powered emergency ventilator |
| 868.5935 |
外用负压呼吸器 |
External negative pressure ventilator |
| 868.5955 |
间歇式强制换气附件 |
Intermittent mandatory ventilation attachment |
| 868.5965 |
正呼气末压式呼吸附件 |
Positive end expiratory pressure breathing attachment |
| 868.5975 |
呼吸器管道系统 |
Ventilator tubing |
| 868.5995 |
T型排水管 （脱水器） |
Tee drain （water trap） |
| G亚部 ――其它器械（Miscellaneous） |
| 868.6100 |
麻醉柜、桌或托盘 |
Anesthetic cabinet, table, or tray |
| 868.6175 |
心肺急救车 |
Cardiopulmonary emergency cart |
| 868.6225 |
鼻夹 |
Nose clip |
| 868.6250 |
便携式空气压缩机 |
Portable air compressor |
| 868.6400 |
校准气体 |
Calibration gas |
| 868.6700 |
麻醉凳 |
Anesthesia stool |
| 868.6810 |
气管支气管吸引导管 |
Tracheobronchial suction catheter |
| 868.6820 |
患者体位支持器 |
Patient position support |
| 868.6885 |
医用气体连接部件 |
Medical gas yoke assembly |
