ClearanceBrief
510(k) K242967 ยท SDY Loss Of Pulse Notification Software

Loss of Pulse Detection

ApplicantFitbit, San Francisco CA, US
DecisionSubstantially Equivalent, Feb 25, 2025
ReceivedSep 26, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K242967

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.