510(k) K033617

EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY by Vasomedical, Inc. — Product Code DRN

K033617 is an FDA 510(k) premarket notification submitted by Vasomedical, Inc. for the device "EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY". The FDA issued a decision of Substantially Equivalent on March 1, 2004. 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.