ClearanceBrief
510(k) K241160 ยท GXY Electrode, Cutaneous

CAIs Sensor (CAIs-001)

ApplicantBrainu Co., Ltd., Seongnam-Si, KR
DecisionSubstantially Equivalent, Dec 13, 2024
ReceivedApr 26, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K241160

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.