ClearanceBrief
510(k) K183654 ยท EOQ Bronchoscope (Flexible Or Rigid)

PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus

ApplicantPentax of America, Inc., Montvale NJ, US
DecisionSubstantially Equivalent, May 23, 2019
ReceivedDec 27, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K183654

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.