EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER

EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER is an FDA 510(k)-cleared medical device (K020857) 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 June 13, 2002. Regulation: 8.