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医疗器械中英文对照--耳鼻喉器械 (Ear,Nose,and Throat Devices)

(《联邦规章典集》第21篇第874部[21CFR874])
   目录
节号
中译文
原英文
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