ClearanceBrief
510(k) K230148 ยท GWL Amplifier, Physiological Signal

Vlab

ApplicantDormotech Medical, Ltd., Afula, IL
DecisionSubstantially Equivalent, Oct 11, 2023
ReceivedJan 19, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K230148

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.