耳鼻喉医疗器械中英文对照

来源： 2018-02-28 16:48中

Ear，Nose，and Throat Devices

　　A亚部――总则（General Provisions）

　　874.1 　　范围

　　874.3
　　Effective dates of requirement for premarket approval

　　874.9
　　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

　　874.1060
　　Acoustic chamber for audiometric testing

　　874.1070
　　Short increment sensitivity index （SISI） adapter

　　874.1080
　　Audiometer calibration set

　　874.1090
　　Auditory impedance tester

　　874.1100
　　Earphone cushion for audiometric testing

　　874.1120
　　Electronic noise generator for audiometric testing

　　874.1325
　　Electroglottograph

　　874.1500
　　Gustometer

　　874.1800
　　Air or water caloric stimulator

　　874.1820
　　Surgical nerve stimulator/locator

　　874.1925
　　Toynbee diagnostic tube

　　C亚部 [保留]（Reserved）

　　D亚部――修复器械（Prosthetic Devices）

　　874.3300 　　助听器

　　874.3310
　　Hearing aid calibrator and analysis system

　　874.3320
　　Group hearing aid or group auditory trainer

　　874.3330
　　Master hearing aid

　　874.3375
　　Battery-powered artificial larynx

　　874.3400
　　Tinnitus masker

　　874.3430
　　Middle ear mold

　　874.3450
　　Partial ossicular replacement prosthesis

　　874.3495
　　Total ossicular replacement prosthesis

　　874.3540
　　Prosthesis modification instrument for ossicular replacement surgery

　　874.3620
　　Ear, nose, and throat synthetic polymer material

　　874.3695
　　Mandibular implant facial prosthesis

　　874.3730
　　Laryngeal prosthesis （Taub design）

　　874.3760
　　Sacculotomy tack （Cody tack）

　　874.3820
　　Endolymphatic shunt

　　874.3850
　　Endolymphatic shunt tube with valve

　　874.3880
　　Tympanostomy tube

　　874.3900
　　Nasal dilator

　　874.3930
　　Tympanostomy tube with semipermeable membrane

　　874.3950
　　Transcutaneous air conduction hearing aid system

　　E亚部――手术器械（Surgical Devices）

　　874.4100 　　鼻出血球囊

　　874.4140
　　Ear, nose, and throat bur

　　874.4175
　　Nasopharyngeal catheter

　　874.4250
　　Ear, nose, and throat electric or pneumatic surgical drill

　　874.4350
　　Ear, nose, and throat fiberoptic light source and carrier

　　874.4420
　　Ear, nose, and throat manual surgical instrument

　　874.4490
　　Argon laser for otology, rhinology, and laryngology

　　874.4500
　　Ear, nose, and throat microsurgical carbon dioxide laser

　　874.4680
　　Bronchoscope （flexible or rigid） and accessories

　　874.4710
　　Esophagoscope （flexible or rigid） and accessories

　　874.4720
　　Mediastinoscope and accessories

　　874.4750
　　Laryngostroboscope

　　874.4760
　　Nasopharyngoscope （flexible or rigid） and accessories

　　874.4770
　　Otoscope

　　874.4780
　　Intranasal splint

　　874.4800
　　Bone particle collector

　　F亚部 ――治疗器械（Therapeutic Devices）

　　874.5220
　　Ear, nose, and throat drug administration device

　　874.5300
　　Ear, nose, and throat examination and treatment unit

　　874.5350
　　Suction antichoke device

　　874.5370
　　Tongs antichoke device

　　874.5550
　　Powered nasal irrigator

　　874.5800
　　External nasal splint

　　874.5840
　　Antistammering device