510(k) K043282 ยท BZD Ventilator, Non-Continuous (Respirator)
DEVILBISS AUTOADJUST, MODEL 9054 SERIES
| Applicant | Sunrise Medical, Somerset PA, US |
| Decision | Substantially Equivalent, Feb 11, 2005 |
| Received | Nov 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043282
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.