510(k) K130481 ยท BZD Ventilator, Non-Continuous (Respirator)
SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
| Applicant | Circadiance, LLC, Murrysville PA, US |
| Decision | Substantially Equivalent, May 24, 2013 |
| Received | Feb 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130481
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.