510(k) K222822 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
| Applicant | Draegerwerk AG & CO Kgaa, Luebeck, DE |
| Decision | Substantially Equivalent, Jun 14, 2023 |
| Received | Sep 19, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222822
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.