ANNE™ One SA-002
ANNE™ One SA-002 is a Class II device made by Sibel Health Inc., cleared under FDA 510(k) K211305 on 14 Sep 2021 and listed in FDA GUDID since 20 Oct 2021 (UDI-DI 00860004541707), 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 | Number00860004541707 | Date20 Oct 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211305 | Date14 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 00860004541707
- FDA 510(k) database K211305
Across registries
- FDA 510(k) K211305 decided 14 Sep 2021 Active
- FDA GUDID UDI-DI 00860004541707 listed 20 Oct 2021 Listed
Timeline
- Cleared FDA 510(k) K211305
- Listed FDA GUDID 00860004541707
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ANNE™ One
- Generic name
- Wearable multiple physiological parameter recorder, reusable
- Model / reference
- SA-002
- Primary DI / UDI-DI
- 00860004541707
- 510(k) Number
- FDA product code
- DRG, MWI, FLL
- GMDN term
- Wearable multiple physiological parameter recorder, reusable
- Device class
- Class II
- Regulation number
- 870.2910, 870.2300, 880.2910
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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