510(k) K032056 ยท BZD Ventilator, Non-Continuous (Respirator)
BILEVEL CPAP, MODEL 9055 SERIES
| Applicant | Sunrise Medical, Somerset PA, US |
| Decision | Substantially Equivalent, Feb 20, 2004 |
| Received | Jul 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032056
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.