EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY

EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY is an FDA 510(k)-cleared medical device (K033617) manufactured by Vasomedical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 29, 2004. Regulation: 8.