510(k) K250231

Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) by Dongguan E-Test Technology Co., Ltd. — Product Code DXN

K250231 is an FDA 510(k) premarket notification submitted by Dongguan E-Test Technology Co., Ltd. for the device "Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)". The FDA issued a decision of Substantially Equivalent on September 3, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Dongguan E-Test Technology Co., Ltd. has at least 4 other 510(k) clearances on record.