510(k) K093124 ยท BZD Ventilator, Non-Continuous (Respirator)
PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03
| Applicant | Cardinal Health 207, Inc., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Mar 10, 2010 |
| Received | Oct 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093124
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.