ClearanceBrief
510(k) K162092 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive

Evolv Model BP7000 Upper Arm Blood Pressure Monitor

ApplicantOmron Healthcare, Inc., Lake Forest IL, US
DecisionSubstantially Equivalent, Nov 22, 2016
ReceivedJul 28, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K162092

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.