510(k) K241590

Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) by Guangdong Xinyu Electronic and Technology Co., Ltd. — Product Code DXN

K241590 is an FDA 510(k) premarket notification submitted by Guangdong Xinyu Electronic and Technology Co., Ltd. for the device "Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)". The FDA issued a decision of Substantially Equivalent on February 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. Guangdong Xinyu Electronic and Technology Co., Ltd. has at least 1 other 510(k) clearance on record.