SDV

Clinical Electronic Thermometer

产品代码

SDV

器械名称

Clinical Electronic Thermometer

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 880.2910

FDA 专业组

General Hospital

上市路径

豁免 510(k)（仍须遵守通用控制与注册列名）

FDA 分类定义

A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。