K060546 is an FDA 510(k) clearance for the BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30. This device is classified as a Ventilator, Continuous, Non-life-supporting (Class II - Special Controls, product code MNS).
Submitted by Breas Medical AB (Molnlycke, Vastra Gotaland, SE). The FDA issued a Cleared decision on May 26, 2006, 86 days after receiving the submission on March 1, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K060546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2006 |
| Decision Date | May 26, 2006 |
| Days to Decision | 86 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 |