510(k) K100343 ยท BZD Ventilator, Non-Continuous (Respirator)
PAP-CAP
| Applicant | Pur-Sleep, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Apr 23, 2010 |
| Received | Feb 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100343
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.