510(k) K242769 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
| Applicant | Draegerwerk AG & CO Kgaa, Luebeck, DE |
| Decision | Substantially Equivalent, Apr 4, 2025 |
| Received | Sep 13, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242769
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.