510(k) K251920 ยท BZD Ventilator, Non-Continuous (Respirator)
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
| Applicant | Dcstar, Inc., New York NY, US |
| Decision | Substantially Equivalent, May 21, 2026 |
| Received | Jun 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251920
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.