As-P65
As-P65 is a Class II device made by Cardicare Company Ltd, cleared under FDA 510(k) K082542 on 17 Sep 2008 and listed in FDA GUDID since 14 May 2018 (UDI-DI 06970366970023), 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 | Number06970366970023 | Date14 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082542 | Date17 Sep 2008 | StatusActive |
Official records
- AccessGUDID record 06970366970023
- FDA 510(k) database K082542
Across registries
- FDA 510(k) K082542 decided 17 Sep 2008 Active
- FDA GUDID UDI-DI 06970366970023 listed 14 May 2018 Listed
Timeline
- Cleared FDA 510(k) K082542
- Listed FDA GUDID 06970366970023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Aneroid manual sphygmomanometer
- Model / reference
- AS-P65
- Primary DI / UDI-DI
- 06970366970023
- 510(k) Number
- FDA product code
- DXQ
- GMDN term
- Aneroid manual sphygmomanometer
- Device class
- Class II
- Regulation number
- 870.1120
- GUDID distribution status
- In Commercial Distribution
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