510(k) K211288

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B by Microlife Intellectual Property GmbH — Product Code DXN

K211288 is an FDA 510(k) premarket notification submitted by Microlife Intellectual Property GmbH for the device "Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B". The FDA issued a decision of Substantially Equivalent on November 4, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Microlife Intellectual Property GmbH has at least 10 other 510(k) clearances on record.