SDV

Clinical Electronic Thermometer

Product code

SDV

Device name

Clinical Electronic Thermometer

Device class

Class 2

21 CFR

21 CFR 880.2910

Medical specialty

General Hospital

Marketing pathway

510(K) Exempt

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).