510(k) K030854 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
| Applicant | E-Z-Em, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Apr 16, 2003 |
| Received | Mar 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030854
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.