ClearanceBrief
510(k) K222101 ยท HCC Device, Biofeedback

Prism

ApplicantGraymatters Health , Ltd., Haifa, IL
DecisionSubstantially Equivalent, Mar 17, 2023
ReceivedJul 18, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K222101

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.