510(k) K223120
K223120 is an FDA 510(k) premarket notification submitted by Flight Medical Innovations , Ltd. for the device "Ventoux VC2; Ventoux VC3". The FDA issued a decision of Substantially Equivalent on December 2, 2024. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Flight Medical Innovations , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2024
- Date Received
- October 3, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type