CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM

CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM is an FDA 510(k)-cleared medical device (K862375) manufactured by Grandcor Medical Systems. 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 30, 1986. Regulation: 8.