510(k) K200480 ยท BZD Ventilator, Non-Continuous (Respirator)
DreamStation 2 System, DreamStation 2 Advanced System
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jul 10, 2020 |
| Received | Feb 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200480
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.