CARDIAC ACQUISITION SYSTEM, ICR 2001

CARDIAC ACQUISITION SYSTEM, ICR 2001 is an FDA 510(k)-cleared medical device (K770705) manufactured by Instruments For Cardiac Research. 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 1, 1977. Regulation: 8.