耳鼻喉器械-(Ear-Nose-and-Throat-Devices)

医疗器械中英文对照－－耳鼻喉器械(Ear，Nose，andThroatDevices)（《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（GeneralProvisions）874.1范围Scope874.3有关上市前批准生效日期的要求Effectivedatesofrequirementforpremarketapproval874.9联邦食品、药品和化妆品法（FederalFood,Drug,andCosmeticAct，FDCA）第510（k）节的豁免限制Limitationsofexemptionsfromsection510(k)oftheFederalFood,Drug,andCosmeticAct(theact)B亚部――诊断器械（DiagnosticDevices）874.1050听度计Audiometer874.1060听力测试用听音室Acousticchamberforaudiometrictesting874.1070短增量灵敏度指数(SISI)适配器Shortincrementsensitivityindex(SISI)adapter874.1080听度计校准装置Audiometercalibrationset874.1090听觉阻抗检测器Auditoryimpedancetester874.1100听力测试用耳机垫Earphonecushionforaudiometrictesting874.1120听力测试用电子噪声发生器Electronicnoisegeneratorforaudiometrictesting874.1325舌动电流描记器Electroglottograph874.1500味觉计Gustometer874.1800空气或水热量刺激器Airorwatercaloricstimulator874.1820外科神经刺激器/定位器Surgicalnervestimulator/locator874.1925托因比诊断管ToynbeediagnostictubeC亚部[保留]（Reserved）D亚部――修复器械（ProstheticDevices）874.3300助听器HearingAid874.3310助听器校准器与分析系统Hearingaidcalibratorandanalysissystem874.3320集体助听器或集体听觉训练器Grouphearingaidorgroupauditorytrainer874.3330主助听器Masterhearingaid874.3375电池驱动的人工喉Battery-poweredartificiallarynx874.3400耳鸣遮蔽器Tinnitusmasker874.3430中耳铸模Middleearmold874.3450局部听小骨置换假体Partialossicularreplacementprosthesis874.3495完整听小骨置换假体Totalossicularreplacementprosthesis874.3540听小骨置换手术用假体修复器具Prosthesismodificationinstrumentforossicularreplacementsurgery874.3620耳鼻喉合成聚合物材料Ear,nose,andthroatsyntheticpolymermaterial874.3695颚植入面部假体Mandibularimplantfacialprosthesis874.3730喉假体(Taub设计)Laryngealprosthesis(Taubdesign)874.3760球囊切开钉(科迪钉)Sacculotomytack(Codytack)874.3820内淋巴分流器Endolymphaticshunt874.3850带阀门的内淋巴分流管Endolymphaticshunttubewithvalve874.3880鼓膜穿刺管Tympanostomytube874.3900鼻扩张器Nasaldilator874.3930带半渗透膜的鼓膜穿刺管Tympanostomytubewithsemipermeablemembrane874.3950经皮空气传导助听器系统TranscutaneousairconductionhearingaidsystemE亚部――手术器械（SurgicalDevices）874.4100鼻出血球囊Epistaxisballoon874.4140耳鼻喉圆头锉Ear,nose,andthroatbur874.4175鼻咽导管Nasopharyngealcatheter874.4250耳鼻喉电动或气动手术钻Ear,nose,andthroatelectricorpneumaticsurgicaldrill874.4350耳鼻喉光纤光源与传输体Ear,nose,andthroatfiberopticlightsourceandcarrier874.4420耳鼻喉手动手术设备Ear,nose,andthroatmanualsurgicalinstrument874.4490耳鼻喉科用氩激光器Argonlaserforotology,rhinology,andlaryngology874.4500耳鼻喉显微手术二氧化碳激光器Ear,nose,andthroatmicrosurgicalcarbondioxidelaser874.4680气管镜(柔性或刚性)及附件Bronchoscope(flexibleorrigid)andaccessories874.4710食管镜(柔性或刚性)及附件Esophagoscope(flexibleorrigid)andaccessories874.4720纵隔镜及附件Mediastinoscopeandaccessories874.4750喉动态镜Laryngostroboscope874.4760喉动态镜(柔性或刚性)及附件Nasopharyngoscope(flexibleorrigid)andaccessories874.4770耳镜Otoscope874.4780鼻内夹板Intranasalsplint874.4800骨粒收集器BoneparticlecollectorF亚部――治疗器械（TherapeuticDevices）874.5220耳鼻喉给药装置Ear,nose,andthroatdrugadministrationdevice874.5300耳鼻喉检查与治疗装置Ear,nose,andthroatexaminationandtreatmentunit874.5350抽吸式抗窒息装置Suctionantichokedevice874.5370抗窒息夹具Tongsantichokedevice874.5550电动鼻清洗器Powerednasalirrigator874.5800鼻外夹板Externalnasalsplint874.5840治疗口吃装置Antistammeringdevice