ClearanceBrief
510(k) K213733 ยท LXB Hearing Aid, Bone Conduction

Ponto 5 SuperPower

ApplicantOticon Medical AB, Askim, SE
DecisionSubstantially Equivalent, Dec 16, 2021
ReceivedNov 26, 2021
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K213733

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.