510(k) K061099 ยท BZD Ventilator, Non-Continuous (Respirator)
BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003
| Applicant | Hoffman Laboratories, LLC, Chatsworth CA, US |
| Decision | Substantially Equivalent, Aug 11, 2006 |
| Received | Apr 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061099
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.