Niox Vero
by Circassia AB
510(k) K170983
Niox Vero 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) K170983 on 22 Nov 2017, 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 | FDA 510(k)SESE | NumberK170983 | Date22 Nov 2017 | StatusActive |
Official records
- FDA 510(k) database K170983
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MXA
- Device class
- Class II
- Regulation
- 21 CFR Part 862.3080
- Advisory committee
- Clinical Toxicology
- FDA decision
- SESE Substantially Equivalent
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