Innocor INN00010
Innocor INN00010 is a Class II device made by Innovision ApS, cleared under FDA 510(k) K083879 on 23 Feb 2009 (2 earlier submissions) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05713867000001), 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 | Number05713867000001 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083879 | Date23 Feb 2009 | StatusActive |
Official records
- AccessGUDID record 05713867000001
- FDA 510(k) database K083879
- FDA 510(k) database K071911
- FDA 510(k) database K051907
Across registries
- FDA 510(k) K083879 decided 23 Feb 2009 Active
- FDA GUDID UDI-DI 05713867000001 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K051907
- Cleared FDA 510(k) K071911
- Cleared FDA 510(k) K083879
- Listed FDA GUDID 05713867000001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Innocor
- Generic name
- Cardiopulmonary stress exercise monitoring system
- Model / reference
- INN00010
- Primary DI / UDI-DI
- 05713867000001
- FDA product code
- BZG, DQK
- GMDN term
- Cardiopulmonary stress exercise monitoring system
- Device class
- Class II
- Regulation number
- 868.1840, 870.1425
- GUDID distribution status
- In Commercial Distribution
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