NIOX Apps / Panel
by Circassia AB
NIOX Apps / Panel (12-1004) is a medical device (FDA Class II; FDA product code MXA, System,Test,Breath Nitric Oxide) made by Circassia AB, cleared under FDA 510(k) K123683 on 27 Dec 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 07350047030519), 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 | Number07350047030519 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123683 | Date27 Dec 2012 | StatusActive |
Official records
- AccessGUDID record 07350047030519
- FDA 510(k) database K123683
Across registries
- FDA 510(k) K123683 decided 27 Dec 2012 Active
- FDA GUDID UDI-DI 07350047030519 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K123683
- Listed FDA GUDID 07350047030519
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Niox
- Generic name
- Patient health record information system application software
- Model / Ref / Catalog
- Apps / Panel, 12-1004
- Primary DI / UDI-DI
- 07350047030519
- 510(k) Number
- FDA product code
- MXA
- GMDN term
- Patient health record information system application software
- Device class
- Class II
- Regulation number
- 862.3080
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Patient health record information system application software.