ClearanceBrief
510(k) K250078 ยท QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

ApplicantMindset Medical, Inc., Phoenix AZ, US
DecisionSubstantially Equivalent, May 30, 2025
ReceivedJan 13, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250078

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.