CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO

CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO is an FDA 510(k)-cleared medical device (K851517) manufactured by Circadian, 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 October 1, 1985. Regulation: 8.