510(k) K894892

HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM by Koven and Assoc., Inc. — Product Code DSB

K894892 is an FDA 510(k) premarket notification submitted by Koven and Assoc., Inc. for the device "HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 27, 1989. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Koven and Assoc., Inc. has at least 7 other 510(k) clearances on record.