NIOX VERO
FDA 510(k) clearance K170983 · decided 2017-11-22
Clearance details
- K-number
- K170983
- Device name
- NIOX VERO
- Applicant
- Circassia AB
- Decision
- Substantially Equivalent
- Date received
- 2017-04-03
- Decision date
- 2017-11-22
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- MXA
- Device class
- 2
- Regulation number
- 862.3080
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.