
Philips Medical Systems
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STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 is an FDA 510(k)-cleared medical device (K080461) 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 March 12, 2008. Regulation: 8.