510(k) K182394 ยท BZD Ventilator, Non-Continuous (Respirator)
WiZARD 310/320 Series CPAP Mask
| Applicant | Apex Medical Corp., New Taipei City, TW |
| Decision | Substantially Equivalent, May 17, 2019 |
| Received | Sep 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182394
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.