K230501
- 510(k) number
- K230501
- Device name
- Spirobank Oxi
- Applicant
- Mir Medical International Research USA WI · US
- Product code
- BZG — Spirometer, Diagnostic
- Decision date
- 2023-12-15
- Date received
- 2023-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K230501.pdf
Official FDA record: K230501
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.