510(k) K063036 ยท BZD Ventilator, Non-Continuous (Respirator)
OPUS HC482 DIRECT NASAL MASK
| Applicant | Fisher & Paykel Healthcare, Ltd., Manukau, NZ |
| Decision | Substantially Equivalent, Dec 22, 2006 |
| Received | Oct 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063036
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.