ClearanceBrief
510(k) K220465 ยท EOB Nasopharyngoscope (Flexible Or Rigid)

PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

ApplicantPentax of America, Inc., Montvale NJ, US
DecisionSubstantially Equivalent, Nov 16, 2022
ReceivedFeb 17, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K220465

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.