510(k) K133009 ยท BZD Ventilator, Non-Continuous (Respirator)
NASAL MASK, NASAL MASK, FULL FACE MASK
| Applicant | BMC Medical Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Apr 23, 2014 |
| Received | Sep 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133009
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.