ClearanceBrief
510(k) K261061 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive

BP Go (BPP-855)

ApplicantWellvii, Inc., Palm Beach Gardens FL, US
DecisionSubstantially Equivalent, Aug 13, 2026
ReceivedMar 31, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K261061

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.