北京译海腾飞翻译公司
联系电话:010-81534401,65677906
公司传真:010-65677906
项目经理:13241835386
联系信箱:81534401@163.com
联系地址:北京市朝阳区南郎家园1号大北写字楼512室(国贸桥东南角,紧邻招商局、海航大厦)
邮政编码:100022
公司网址:http://www.bjyhtf.com
(《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 |