510(k) K260251 ยท BZD Ventilator, Non-Continuous (Respirator)
BreathCare PAP III (YH-390N)
| Applicant | Suzhou Yuyue Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Oct 23, 2026 |
| Received | Jan 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260251
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.