ClearanceBrief
510(k) K250680 ยท SAK Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Bayesian Health Sepsis Flagging Device

ApplicantBayesian Health, Inc., New York NY, US
DecisionSubstantially Equivalent, Apr 30, 2026
ReceivedMar 6, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250680

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.