HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE is an FDA 510(k)-cleared medical device (K871135) manufactured by First Medical Devices Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 11, 1987. Regulation: 8.