K222822 is an FDA 510(k) clearance for the VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608). This device is classified as a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II - Special Controls, product code BZE).
Submitted by Draegerwerk AG & CO Kgaa (Luebeck, DE). The FDA issued a Cleared decision on June 14, 2023, 268 days after receiving the submission on September 19, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K222822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2022 |
| Decision Date | June 14, 2023 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZE - Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5270 |