510(k) K190713 ยท BZD Ventilator, Non-Continuous (Respirator)
F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Oct 11, 2019 |
| Received | Mar 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190713
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.