| 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 |
