510(k) K020857

EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER by Vasomedical, Inc. — Product Code DRN

K020857 is an FDA 510(k) premarket notification submitted by Vasomedical, Inc. for the device "EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER". The FDA issued a decision of Substantially Equivalent on June 14, 2002. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Vasomedical, Inc. has at least 6 other 510(k) clearances on record.