510(k) K161412 · BZD Ventilator, Non-Continuous (Respirator)
F&P Brevida Nasal Pillows Mask
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Jan 18, 2017 |
| Received | May 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161412
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.