510(k) K781906

BLOOD PRESSURE DEVICE, 400 SERIES by Med-Tek Corp. — Product Code DXN

K781906 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "BLOOD PRESSURE DEVICE, 400 SERIES". The FDA issued a decision of Substantially Equivalent on November 16, 1978. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Med-Tek Corp. has at least 10 other 510(k) clearances on record.