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