K063404 is an FDA 510(k) clearance for the SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Maquet Critical Care AB (Bridgewater, US). The FDA issued a Cleared decision on February 15, 2007, 98 days after receiving the submission on November 9, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K063404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2006 |
| Decision Date | February 15, 2007 |
| Days to Decision | 98 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 |