ClearanceBrief
510(k) K210139 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

ApplicantEdan Instruments, Inc., Shenzhen, CN
DecisionSubstantially Equivalent, Oct 1, 2021
ReceivedJan 19, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K210139

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.