510(k) K052597 ยท BZD Ventilator, Non-Continuous (Respirator)
BREATHEX OMEGA CPAP DEVICE, MODEL 322
| Applicant | Hoffman Laboratories, LLC, Chatsworth CA, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Sep 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052597
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.