ClearanceBrief
510(k) K250161 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive

Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure

ApplicantShenzhen AOJ Medical Technology Co., Ltd., Shenzhen, CN
DecisionSubstantially Equivalent, May 2, 2025
ReceivedJan 21, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250161

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.