ClearanceBrief
510(k) K853381 ยท ESD Hearing Aid, Air-Conduction, Prescription

OE SERIES OF BEHIND-THE-EAR HEARING AIDS

ApplicantEmtech Laboratories, Roanoke VA, US
DecisionSubstantially Equivalent, Nov 8, 1985
ReceivedAug 12, 1985
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K853381

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.