510(k) K003469

EECP THERAPY SYSTEM, MODEL TS3 by Vasomedical, Inc. — Product Code DRN

K003469 is an FDA 510(k) premarket notification submitted by Vasomedical, Inc. for the device "EECP THERAPY SYSTEM, MODEL TS3". The FDA issued a decision of Substantially Equivalent on December 6, 2000. 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.