K251777 is an FDA 510(k) clearance for the MESI mTABLET SPIRO. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Mesi D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on March 2, 2026, 265 days after receiving the submission on June 10, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K251777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2025 |
| Decision Date | March 02, 2026 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |