ClearanceBrief
510(k) K133976 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope

FUJIFILM ENDOSCOPIC CO2 REGULATOR

ApplicantFujifilm Medical System U.S.A., Inc., Wayne NJ, US
DecisionSubstantially Equivalent, Sep 9, 2014
ReceivedDec 26, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K133976

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.