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SDVClass II

Clinical Electronic Thermometer

21 CFR 880.2910 / General Hospital
FDA source (opens on fda.gov)

SDV is the FDA product code for Clinical Electronic Thermometer, a class II device type, regulated under 21 CFR 880.2910. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SDV
Device name
Clinical Electronic Thermometer
FDA 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
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 97 companies shown, in name order