510(k) K053008 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
E-Z-EM ENDOSCOPIC CO2 REGULATOR
| Applicant | E-Z-Em, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Dec 27, 2005 |
| Received | Oct 26, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K053008
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.