510(k) K132192 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
| Applicant | Bracco Diagnostic, Inc., Monroe Township NJ, US |
| Decision | Substantially Equivalent, Feb 14, 2014 |
| Received | Jul 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132192
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.