510(k) K081845 ยท CBK Ventilator, Continuous, Facility Use
IVENT101
| Applicant | Versamed Medical Systems, Inc., Pearl River NY, US |
| Decision | Substantially Equivalent, Mar 16, 2009 |
| Received | Jun 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081845
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.