510(k) K113310 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
ENDOGATER AVANTAGE CO2 INSUFFLATOR
| Applicant | Byrne Medical, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 20, 2012 |
| Received | Nov 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113310
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.