ClearanceBrief
510(k) K182846 ยท EOB Nasopharyngoscope (Flexible Or Rigid)

PENTAX Medical EPK-3000 Video Imaging System

ApplicantPentax of America, Inc., Montvale NJ, US
DecisionSubstantially Equivalent, Jan 9, 2019
ReceivedOct 9, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K182846

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.