510(k) K162905 ยท BZD Ventilator, Non-Continuous (Respirator)
SleepWeaver 3D Nasal Mask
| Applicant | Circadiance, LLC, Turtle Creek PA, US |
| Decision | Substantially Equivalent, Mar 15, 2017 |
| Received | Oct 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162905
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.