510(k) K913595

DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM by Koven and Assoc., Inc. — Product Code DXN

K913595 is an FDA 510(k) premarket notification submitted by Koven and Assoc., Inc. for the device "DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 27, 1992. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Koven and Assoc., Inc. has at least 7 other 510(k) clearances on record.