Ampmed AMPAE3W
by Amplim, LLC
Ampmed AMPAE3W is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K171578 on 30 Nov 2017 and listed in FDA GUDID since 6 May 2021 (UDI-DI 00810477023637), 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 | Number00810477023637 | Date6 May 2021 | StatusListed |
| United States | FDA 510(k) | NumberK171578 | Date30 Nov 2017 | StatusActive |
Official records
- AccessGUDID record 00810477023637
- FDA 510(k) database K171578
Across registries
- FDA 510(k) K171578 decided 30 Nov 2017 Active
- FDA GUDID UDI-DI 00810477023637 listed 6 May 2021 Listed
Timeline
- Cleared FDA 510(k) K171578
- Listed FDA GUDID 00810477023637
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- Withdrawn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
- AMPAE3W
- Primary DI / UDI-DI
- 00810477023637
- 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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