K053607 is an FDA 510(k) clearance for the BREAS VIVO 40 SYSTEM. This device is classified as a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II - Special Controls, product code MNT).
Submitted by Breas Medical AB (Molnlycke, Vastra Gotaland, SE). The FDA issued a Cleared decision on March 16, 2006, 79 days after receiving the submission on December 27, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K053607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2005 |
| Decision Date | March 16, 2006 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNT - Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |