MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11

MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 is an FDA 510(k)-cleared medical device (K900607) manufactured by Cardiodata 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 October 15, 1990. Regulation: 8.