510(k) K013219 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
PROTOCO2L INSUFFLATOR MODEL 6400
| Applicant | E-Z-Em, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Feb 19, 2002 |
| Received | Sep 26, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K013219
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.