510(k) K071915 ยท BZD Ventilator, Non-Continuous (Respirator)
CPAP MASK
| Applicant | Arcimed Laboratories, LLC, Bonita Springs FL, US |
| Decision | Substantially Equivalent, May 14, 2008 |
| Received | Jul 11, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071915
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.