510(k) K163464 ยท BZD Ventilator, Non-Continuous (Respirator)
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
| Applicant | Bmc Medical., Ltd., Haidian, CN |
| Decision | Substantially Equivalent, Sep 5, 2017 |
| Received | Dec 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163464
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.