510(k) K851664

MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO by Sharp Electronics Corp. — Product Code DXN

K851664 is an FDA 510(k) premarket notification submitted by Sharp Electronics Corp. for the device "MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO". The FDA issued a decision of Substantially Equivalent on July 24, 1985. 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.