Andesfit ADF-B61
Andesfit ADF-B61 is a Class II device made by Andesfit Limited, cleared under FDA 510(k) K160019 on 22 Apr 2016 and listed in FDA GUDID since 2 May 2023 (UDI-DI 04897100310254), 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 | Number04897100310254 | Date2 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160019 | Date22 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 04897100310254
- FDA 510(k) database K160019
Across registries
- FDA 510(k) K160019 decided 22 Apr 2016 Active
- FDA GUDID UDI-DI 04897100310254 listed 2 May 2023 Listed
Timeline
- Cleared FDA 510(k) K160019
- Listed FDA GUDID 04897100310254
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Andesfit
- Generic name
- Automatic-inflation electronic sphygmomanometer, non-portable
- Model / reference
- ADF-B61
- Primary DI / UDI-DI
- 04897100310254
- 510(k) Number
- FDA product code
- DXN
- GMDN term
- Automatic-inflation electronic sphygmomanometer, non-portable
- Device class
- Class II
- Regulation number
- 870.1130
- GUDID distribution status
- In Commercial Distribution
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