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Philips Medical Systems
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ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O is an FDA 510(k)-cleared medical device (K101521) manufactured by Philips Medical Systems. 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 28, 2010. Regulation: 8.