510(k) K253044 ยท BZD Ventilator, Non-Continuous (Respirator)
RXiBreeze PAP System (RXiBreeze 20C)
| Applicant | Resvent Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 23, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253044
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.