510(k) K092135 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO IVENT 101
| Applicant | Versamed Medical Systems , Ltd., Madison WI, US |
| Decision | Substantially Equivalent, Nov 23, 2009 |
| Received | Jul 15, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092135
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.