510(k) K080692 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
MACS CPAP SYSTEM
| Applicant | Airon Corporation, Melbourne FL, US |
| Decision | Substantially Equivalent, Jun 20, 2008 |
| Received | Mar 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080692
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.