SDV — Clinical Electronic Thermometer Class II
FDA product code SDV covers "Clinical Electronic Thermometer", a Class II medical device regulated under 21 CFR 880.2910. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- SDV
- Device Class
- Class II
- Regulation Number
- 880.2910
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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