HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER

HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER is an FDA 510(k)-cleared medical device (K980144) manufactured by Aerotel, 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 June 15, 1998. Regulation: 8.