ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0

ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 is an FDA 510(k)-cleared medical device (K014261) manufactured by Philips Medical Systems, 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 February 11, 2002. Regulation: 8.