K230173 is an FDA 510(k) clearance for the Servo-air Lite Ventilator System. This device is classified as a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II - Special Controls, product code MNT).
Submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on July 6, 2023, 167 days after receiving the submission on January 20, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K230173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2023 |
| Decision Date | July 06, 2023 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNT - Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |