ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.

ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. is an FDA 510(k)-cleared medical device (K021251) 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 May 6, 2002. Regulation: 8.