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Spacelabs Medical, Inc.
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QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 is an FDA 510(k)-cleared medical device (K021097) manufactured by Spacelabs Medical, 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 June 27, 2002. Regulation: 8.