510(k) K222822
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) by
Draegerwerk AG & CO Kgaa
— Product Code BZE
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2023
- Date Received
- September 19, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Device Class
- Class II
- Regulation Number
- 868.5270
- Review Panel
- AN
- Submission Type