510(k) K083832 ยท BZD Ventilator, Non-Continuous (Respirator)
ZEST NASAL MASK
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, NZ |
| Decision | Substantially Equivalent, Mar 16, 2009 |
| Received | Dec 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083832
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.