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Cambridge Heart, Inc.
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ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM is an FDA 510(k)-cleared medical device (K012206) manufactured by Cambridge Heart, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 2001. Regulation: 8.