510(k) K061034 ยท BZD Ventilator, Non-Continuous (Respirator)
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jun 23, 2006 |
| Received | Apr 14, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061034
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.