Infrared Forehead Thermometer 5613
Infrared Forehead Thermometer 5613 is a Class II device made by Dynarex Corp., cleared under FDA 510(k) K131243 on 12 Nov 2013 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00616784561325), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00616784561325 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131243 | Date12 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 00616784561325
- FDA 510(k) database K131243
Across registries
- FDA 510(k) K131243 decided 12 Nov 2013 Active
- FDA GUDID UDI-DI 00616784561325 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K131243
- Listed FDA GUDID 00616784561325
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Infrared Forehead Thermometer
- Generic name
- Infrared patient thermometer, skin
- Model / reference
- 5613
- Primary DI / UDI-DI
- 00616784561325
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Infrared patient thermometer, skin
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Infrared patient thermometer, skin.