510(k) K780046

ULTRASPHYG BLOOD PRESSURE OPTION by Cavitron Corp. — Product Code DXN

K780046 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "ULTRASPHYG BLOOD PRESSURE OPTION". The FDA issued a decision of Substantially Equivalent on March 15, 1978. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Cavitron Corp. has at least 10 other 510(k) clearances on record.