K201874 is an FDA 510(k) clearance for the Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1. 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 April 20, 2021, 287 days after receiving the submission on July 7, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K201874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2020 |
| Decision Date | April 20, 2021 |
| Days to Decision | 287 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 |