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耳鼻喉医疗器械中英文对照

来源:长理培训发布时间:2018-02-28 16:48:04

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

责编:李亚林

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