AcuPebble Ox100
AcuPebble Ox100 is a Class II device made by Acurable Limited, cleared under FDA 510(k) K222950 on 3 Feb 2023 and listed in FDA GUDID since 12 Jan 2024 (UDI-DI 05060759090238), 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 | Number05060759090238 | Date12 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222950 | Date3 Feb 2023 | StatusActive |
Official records
- AccessGUDID record 05060759090238
- FDA 510(k) database K222950
Across registries
- FDA 510(k) K222950 decided 3 Feb 2023 Active
- FDA GUDID UDI-DI 05060759090238 listed 12 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K222950
- Listed FDA GUDID 05060759090238
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AcuPebble
- Generic name
- Wearable multiple physiological parameter recorder, reusable
- Model / reference
- Ox100
- Primary DI / UDI-DI
- 05060759090238
- 510(k) Number
- FDA product code
- MNR
- GMDN term
- Wearable multiple physiological parameter recorder, reusable
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
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