510(k) K263254 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)
| Applicant | Xiamen Compower Medical Tech. Co., Ltd., Xiamen, CN |
| Decision | Substantially Equivalent, Oct 16, 2026 |
| Received | Sep 17, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K263254
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.