K151814 is an FDA 510(k) clearance for the SERVO-U Ventilator System, SERVO-n Ventilator System. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on December 21, 2015, 168 days after receiving the submission on July 6, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K151814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2015 |
| Decision Date | December 21, 2015 |
| Days to Decision | 168 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 |