A亚部――总则（General Provisions）

874.1

范围

Scope

874.3

有关上市前批准生效日期的要求

Effective dates of requirement for premarket approval

874.9

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）

874.1050

听度计

Audiometer

874.1060

听力测试用听音室

Acoustic chamber for audiometric testing

874.1070

短增量灵敏度指数(SISI)适配器

Short increment sensitivity index (SISI) adapter

874.1080

听度计校准装置

Audiometer calibration set

874.1090

听觉阻抗检测器

Auditory impedance tester

874.1100

听力测试用耳机垫

Earphone cushion for audiometric testing

874.1120

听力测试用电子噪声发生器

Electronic noise generator for audiometric testing

874.1325

舌动电流描记器

Electroglottograph

874.1500

味觉计

Gustometer

874.1800

空气或水热量刺激器

Air or water caloric stimulator

874.1820

外科神经刺激器/定位器

Surgical nerve stimulator/locator

874.1925

托因比诊断管

Toynbee diagnostic tube

C亚部 [保留]（Reserved）

D亚部――修复器械（Prosthetic Devices）

874.3300

助听器

Hearing Aid

874.3310

助听器校准器与分析系统

Hearing aid calibrator and analysis system

874.3320

集体助听器或集体听觉训练器

Group hearing aid or group auditory trainer

874.3330

主助听器

Master hearing aid

874.3375

电池驱动的人工喉

Battery-powered artificial larynx

874.3400

耳鸣遮蔽器

Tinnitus masker

874.3430

中耳铸模

Middle ear mold

874.3450

局部听小骨置换假体

Partial ossicular replacement prosthesis

874.3495

完整听小骨置换假体

Total ossicular replacement prosthesis

874.3540

听小骨置换手术用假体修复器具

Prosthesis modification instrument for ossicular replacement surgery

874.3620

耳鼻喉合成聚合物材料

Ear, nose, and throat synthetic polymer material

874.3695

颚植入面部假体

Mandibular implant facial prosthesis

874.3730

喉假体(Taub设计)

Laryngeal prosthesis (Taub design)

874.3760

球囊切开钉(科迪钉)

Sacculotomy tack (Cody tack)

874.3820

内淋巴分流器

Endolymphatic shunt

874.3850

带阀门的内淋巴分流管

Endolymphatic shunt tube with valve

874.3880

鼓膜穿刺管

Tympanostomy tube

874.3900

鼻扩张器

Nasal dilator

874.3930

带半渗透膜的鼓膜穿刺管

Tympanostomy tube with semipermeable membrane

874.3950

经皮空气传导助听器系统

Transcutaneous air conduction hearing aid system

E亚部――手术器械（Surgical Devices）

874.4100

鼻出血球囊

Epistaxis balloon

874.4140

耳鼻喉圆头锉

Ear, nose, and throat bur

874.4175

鼻咽导管

Nasopharyngeal catheter

874.4250

耳鼻喉电动或气动手术钻

Ear, nose, and throat electric or pneumatic surgical drill

874.4350

耳鼻喉光纤光源与传输体

Ear, nose, and throat fiberoptic light source and carrier

874.4420

耳鼻喉手动手术设备

Ear, nose, and throat manual surgical instrument

874.4490

耳鼻喉科用氩激光器

Argon laser for otology, rhinology, and laryngology

874.4500

耳鼻喉显微手术二氧化碳激光器

Ear, nose, and throat microsurgical carbon dioxide laser

874.4680

气管镜(柔性或刚性)及附件

Bronchoscope (flexible or rigid) and accessories

874.4710

食管镜(柔性或刚性)及附件

Esophagoscope (flexible or rigid) and accessories

874.4720

纵隔镜及附件

Mediastinoscope and accessories

874.4750

喉动态镜

Laryngostroboscope

874.4760

喉动态镜(柔性或刚性)及附件

Nasopharyngoscope (flexible or rigid) and accessories

874.4770

耳镜

Otoscope

874.4780

鼻内夹板

Intranasal splint

874.4800

骨粒收集器

Bone particle collector

F亚部 ――治疗器械（Therapeutic Devices）

874.5220

耳鼻喉给药装置

Ear, nose, and throat drug administration device

874.5300

耳鼻喉检查与治疗装置

Ear, nose, and throat examination and treatment unit

874.5350

抽吸式抗窒息装置

Suction antichoke device

874.5370

抗窒息夹具

Tongs antichoke device

874.5550

电动鼻清洗器

Powered nasal irrigator

874.5800

鼻外夹板

External nasal splint

874.5840

治疗口吃装置

Antistammering device