510(k) K904344 ยท BZD Ventilator, Non-Continuous (Respirator)
SLEEPER MASK SYSTEM
| Applicant | Devilbiss Health Care, Inc., Somerset PA, US |
| Decision | Substantially Equivalent, May 1, 1991 |
| Received | Sep 24, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904344
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.