510(k) K222822
K222822 is an FDA 510(k) premarket notification submitted by Draegerwerk AG & CO Kgaa for the device "VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)". The FDA issued a decision of Substantially Equivalent on June 14, 2023. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Draegerwerk AG & CO Kgaa has at least 7 other 510(k) clearances on record.
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