Thermometer, Survalent-Electronic
510(k) K760421
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760421 | Date23 Aug 1976 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Thermometer, Survalent-Electronic is an electronic clinical thermometer designed for accurate body temperature measurement in hospital settings. It falls under the FDA classification for electronic thermometers, intended for use in general hospital environments to monitor patient vitals with precision and reliability.
This device is supplied as a reusable electronic unit, regulated under FDA 510(k) clearance (K760421) with a decision of Substantially Equivalent (SESE). It is classified under product code FLL and was authorized for commercial distribution in 1976. No specific sterility or MRI safety information is provided in the regulatory data.