Innocor INN00100-1
Innocor INN00100-1 is a Class II device made by Innovision ApS, cleared under FDA 510(k) K071911 on 7 Sep 2007 (1 earlier submission) and listed in FDA GUDID since 14 Mar 2017 (UDI-DI 05713867000124), 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 | Number05713867000124 | Date14 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071911 | Date7 Sep 2007 | StatusActive |
Official records
- AccessGUDID record 05713867000124
- FDA 510(k) database K071911
- FDA 510(k) database K051907
Across registries
- FDA 510(k) K071911 decided 7 Sep 2007 Active
- FDA GUDID UDI-DI 05713867000124 listed 14 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K051907
- Cleared FDA 510(k) K071911
- Listed FDA GUDID 05713867000124
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Innocor
- Generic name
- Pulmonary function analysis system, paediatric
- Model / reference
- INN00100-1
- Primary DI / UDI-DI
- 05713867000124
- FDA product code
- DQK
- GMDN term
- Pulmonary function analysis system, paediatric
- Device class
- Class II
- Regulation number
- 870.1425
- GUDID distribution status
- In Commercial Distribution
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