K163127 is an FDA 510(k) clearance for the bellavista 1000. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Imtmedical AG (Buchs Sg, CH). The FDA issued a Cleared decision on July 31, 2017, 265 days after receiving the submission on November 8, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K163127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2016 |
| Decision Date | July 31, 2017 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK - Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |