510(k) K251888 ยท CBK Ventilator, Continuous, Facility Use
VPAP Pediatric Face Mask
| Applicant | Hsiner Co., Ltd., Taichung City, TW |
| Decision | Substantially Equivalent, Mar 12, 2026 |
| Received | Jun 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251888
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.