510(k) K930581 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
E-Z-FLATE
| Applicant | E-Z-Em, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Jul 1, 1994 |
| Received | Feb 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930581
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.