510(k) K043607 ยท BZD Ventilator, Non-Continuous (Respirator)
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jan 28, 2005 |
| Received | Dec 30, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043607
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.