RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER

RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER is an FDA 510(k)-cleared medical device (K063609) manufactured by Shl Telemedicine International , 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 September 11, 2007. Regulation: 8.