510(k) K192092

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 by Seca GmbH & Co. KG — Product Code DXN

K192092 is an FDA 510(k) premarket notification submitted by Seca GmbH & Co. KG for the device "Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535". The FDA issued a decision of Substantially Equivalent on January 23, 2020. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Seca GmbH & Co. KG has at least 1 other 510(k) clearance on record.