510(k) K861375

MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS by Sharp Electronics Corp. — Product Code DXN

K861375 is an FDA 510(k) premarket notification submitted by Sharp Electronics Corp. for the device "MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS". The FDA issued a decision of Substantially Equivalent on August 6, 1986. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Sharp Electronics Corp. has at least 9 other 510(k) clearances on record.