
Aerotel Medical Systems (1998) , Ltd.
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HEART 2005 is an FDA 510(k)-cleared medical device (K000775) 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 May 16, 2000. Regulation: 8.