510(k) K130328 ยท BZD Ventilator, Non-Continuous (Respirator)
F&P SIMPLUS FULL FACE MASK
| Applicant | Fisher & Paykel Healthcare Limited, Auckland, NZ |
| Decision | Substantially Equivalent, Jun 5, 2013 |
| Received | Feb 11, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130328
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.