510(k) K173193 ยท BZD Ventilator, Non-Continuous (Respirator)
F&P SleepStyle
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Aug 8, 2018 |
| Received | Oct 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173193
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.