ClearanceBrief
510(k) K211640 ยท LXB Hearing Aid, Bone Conduction

Ponto 5 Mini

ApplicantOticon Medical AB, Askim, SE
DecisionSubstantially Equivalent, Aug 10, 2021
ReceivedMay 27, 2021
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K211640

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.