K231416
- 510(k) number
- K231416
- Device name
- Air Next (NVD-02)
- Applicant
- Nuvoair AB SE
- Product code
- BZG — Spirometer, Diagnostic
- Decision date
- 2024-01-18
- Date received
- 2023-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231416.pdf
Official FDA record: K231416
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.