KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH

KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K862544) manufactured by Suzuken Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 5, 1986. Regulation: 8.