K251777
- 510(k) number
- K251777
- Device name
- MESI mTABLET SPIRO
- Applicant
- Mesi D.O.O. SI
- Product code
- BZG — Spirometer, Diagnostic
- Decision date
- 2026-03-02
- Date received
- 2025-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251777.pdf
Official FDA record: K251777
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.