510(k) K151683 ยท BZD Ventilator, Non-Continuous (Respirator)
SleepWeaver Advance Pediatric Nasal CPAP Mask
| Applicant | Circadiance, LLC, Export PA, US |
| Decision | Substantially Equivalent, Apr 5, 2016 |
| Received | Jun 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151683
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.