510(k) K032834 ยท BZD Ventilator, Non-Continuous (Respirator)
BIPAP PRO 2 BI-LEVEL SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Mar 4, 2004 |
| Received | Sep 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032834
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.