510(k) K212877

Arm Blood Pressure Monitor by Alicn Medical Shenzhen, Inc. — Product Code DXN

K212877 is an FDA 510(k) premarket notification submitted by Alicn Medical Shenzhen, Inc. for the device "Arm Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on January 12, 2022. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Alicn Medical Shenzhen, Inc. has at least 10 other 510(k) clearances on record.