ClearanceBrief
510(k) K223622 ยท QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

FaceHeart Vitals Software Development Kit (FH vitals SDK)

ApplicantFaceheart Corp., Grand Cayman, KY
DecisionSubstantially Equivalent, Sep 1, 2023
ReceivedDec 5, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K223622

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.