ClearanceBrief
510(k) K243687 ยท QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Vital Signs

ApplicantOxehealth Limited, Abingdon, GB
DecisionSubstantially Equivalent, Aug 27, 2025
ReceivedNov 29, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243687

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.