ClearanceBrief
510(k) K231970 ยท EOQ Bronchoscope (Flexible Or Rigid)

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

ApplicantPentax of America, Inc., Montvale NJ, US
DecisionSubstantially Equivalent, Jan 12, 2024
ReceivedJul 3, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231970

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.