510(k) K120757 ยท BZD Ventilator, Non-Continuous (Respirator)
SLEEPWEAVER ELAN NASAL CPAP MASK
| Applicant | Circadiance, LLC, Export PA, US |
| Decision | Substantially Equivalent, Apr 24, 2012 |
| Received | Mar 13, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120757
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.