Peerbridge Cor System COREVENT
Peerbridge Cor System COREVENT is a Class II device made by Peerbridge Health, Inc., cleared under FDA 510(k) K171936 on 27 Sep 2017 and listed in FDA GUDID since 6 Feb 2018 (UDI-DI B608COREVENT0), 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 | NumberB608COREVENT0 | Date6 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171936 | Date27 Sep 2017 | StatusActive |
Official records
- FDA 510(k) database K171936
Across registries
- FDA 510(k) K171936 decided 27 Sep 2017 Active
- FDA GUDID UDI-DI B608COREVENT0 listed 6 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K171936
- Listed FDA GUDID B608COREVENT0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Peerbridge Cor System
- Generic name
- Wearable multiple physiological parameter recorder, reusable
- Model / Ref / Catalog
- COREVENT
- Primary DI / UDI-DI
- B608COREVENT0
- 510(k) Number
- FDA product code
- DSH
- GMDN term
- Wearable multiple physiological parameter recorder, reusable
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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