K041223 is an FDA 510(k) clearance for the MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E. 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 July 29, 2004, 80 days after receiving the submission on May 10, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K041223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2004 |
| Decision Date | July 29, 2004 |
| Days to Decision | 80 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 |