- 讲师:刘萍萍 / 谢楠
- 课时:160h
- 价格 4580 元
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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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