K223120 is an FDA 510(k) clearance for the Ventoux VC2. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Flight Medical Innovations , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on December 2, 2024, 791 days after receiving the submission on October 3, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K223120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2022 |
| Decision Date | December 02, 2024 |
| Days to Decision | 791 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 |