510(k) K090879 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
INSUFLOW CO2IONSHIELD
| Applicant | Lexion Medical, LLC, St. Paul MN, US |
| Decision | Substantially Equivalent, Jul 23, 2009 |
| Received | Mar 31, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090879
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.