510(k) K253166 ยท BZD Ventilator, Non-Continuous (Respirator)
F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
| Applicant | BMC Medical Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Apr 29, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253166
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.