Electronic Clinical Thermometer (K780861)
510(k) K780861
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780861 | Date10 Aug 1978 | 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- Withdrawn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
- Full name
- Electronic Clinical Thermometer
- 510(k) Number
- FDA Product Code
- FLL
- FDA applicant
- Trend Medical, Inc.
- 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 Electronic Clinical Thermometer (K780861) is a medical device classified as an electronic thermometer, designed to measure body temperature via a transducer linked to an electronic display unit. It amplifies, conditions, and digitally presents temperature readings for clinical assessment, ensuring rapid and accurate patient monitoring.
This device is intended for single-use or reusable applications in general hospital settings, as determined by the FDA’s 510(k) review process. Supplied sterile or non-sterile based on model specifications, it adheres to FDA clearance (K780861) under the product code FLL. Storage and handling follow manufacturer guidelines to maintain accuracy and hygiene.