510(k) K173060 ยท CBK Ventilator, Continuous, Facility Use
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
| Applicant | Fisher and Paykel Healthcare Limited, Auckland, NZ |
| Decision | Substantially Equivalent, Jan 25, 2018 |
| Received | Sep 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173060
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.