510(k) K092362 ยท BZD Ventilator, Non-Continuous (Respirator)
SLEEPWEAVER NASAL CPAP MASK
| Applicant | Circadiance, LLC, Murrysville PA, US |
| Decision | Substantially Equivalent, Nov 2, 2009 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092362
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.