Submission Details
| 510(k) Number | K230173 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Servo-air Lite Ventilator System
Jul 2023
Decision
167d
Days
Class 2
Risk
About This 510(k) Submission
K230173 is an FDA 510(k) clearance for the Servo-air Lite Ventilator System, 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 review panel. Regulated under 21 CFR 868.5895.
Device Classification
| Product Code | MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5895 |
Manufacturer
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