510(k) K011229 ยท BZD Ventilator, Non-Continuous (Respirator)
DEVILBISS 9000 SERIES CPAP, MODEL 9001
| Applicant | Sunrise Medical Hhg, Inc., Somerset PA, US |
| Decision | Substantially Equivalent, Jul 11, 2001 |
| Received | Apr 23, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011229
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.