510(k) K222153

Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) by Microlife Intellectual Property GmbH — Product Code DXN

K222153 is an FDA 510(k) premarket notification submitted by Microlife Intellectual Property GmbH for the device "Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)". The FDA issued a decision of Substantially Equivalent on Feb 3, 2023. 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 53 other 510(k) clearances on record.