510(k) K180779 · CBK Ventilator, Continuous, Facility Use
Savina 300
| Applicant | Dragerwerk AG & CO Kgaa, Lübeck, DE |
| Decision | Substantially Equivalent, Jan 17, 2019 |
| Received | Mar 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180779
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.