Thermofinder Fs-300
Thermofinder Fs-300 is a Class II device made by HuBDIC Co., Ltd., cleared under FDA 510(k) K130361 on 2 Apr 2013 and listed in FDA GUDID since 13 Apr 2022 (UDI-DI 08800132200161), 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 | Number08800132200161 | Date13 Apr 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130361 | Date2 Apr 2013 | StatusActive |
Official records
- AccessGUDID record 08800132200161
- FDA 510(k) database K130361
Across registries
- FDA 510(k) K130361 decided 2 Apr 2013 Active
- FDA GUDID UDI-DI 08800132200161 listed 13 Apr 2022 Listed
Timeline
- Cleared FDA 510(k) K130361
- Listed FDA GUDID 08800132200161
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Thermofinder
- Generic name
- Infrared patient thermometer, skin
- Model / reference
- FS-300
- Primary DI / UDI-DI
- 08800132200161
- 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
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