510(k) K243023 ยท BZD Ventilator, Non-Continuous (Respirator)
WiZARD 520 Full Face Mask
| Applicant | Wellell, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, May 23, 2025 |
| Received | Sep 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243023
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.