Clearance Summary
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) received FDA 510(k) clearance under submission number K222822, sponsored by Draegerwerk AG & CO Kgaa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2023-06-14.
- Submission: K222822
- Applicant / Sponsor: Draegerwerk AG & CO Kgaa
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5270
- Decision date: 2023-06-14
Classification & Regulation
This clearance is catalogued under FDA product code BZE and 21 CFR 868.5270, within the Anesthesiology review panel as a Class II device.