MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM

MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM is an FDA 510(k)-cleared medical device (K895801) manufactured by Marquette Electronics, 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 April 3, 1990. Regulation: 8.