Ampmed AMPCA1W
by Amplim, LLC
Ampmed AMPCA1W is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K191251 on 15 Oct 2019 and listed in FDA GUDID since 6 May 2021 (UDI-DI 00810477023606), active as of 22 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 | Number00810477023606 | Date6 May 2021 | StatusListed |
| United States | FDA 510(k) | NumberK191251 | Date15 Oct 2019 | StatusActive |
Official records
- AccessGUDID record 00810477023606
- FDA 510(k) database K191251
Across registries
- FDA 510(k) K191251 decided 15 Oct 2019 Active
- FDA GUDID UDI-DI 00810477023606 listed 6 May 2021 Listed
Timeline
- Cleared FDA 510(k) K191251
- Listed FDA GUDID 00810477023606
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ampmed
- Generic name
- Infrared patient thermometer, skin
- Model / reference
- AMPCA1W
- Primary DI / UDI-DI
- 00810477023606
- 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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