K240778 is an FDA 510(k) clearance for the Vivo 1, Vivo 2. This device is classified as a Ventilator, Continuous, Non-life-supporting (Class II - Special Controls, product code MNS).
Submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on December 13, 2024, 267 days after receiving the submission on March 21, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K240778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2024 |
| Decision Date | December 13, 2024 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNS - Ventilator, Continuous, Non-life-supporting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |