
Aerotel Medical Systems (1998) , Ltd.
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HEARTLINE RECEIVING STATION is an FDA 510(k)-cleared medical device (K022073) manufactured by Aerotel Medical Systems (1998) , 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 July 23, 2002. Regulation: 8.