CALG-STR EXERCISE ECG ANALYSIS ALGORITHM

CALG-STR EXERCISE ECG ANALYSIS ALGORITHM is an FDA 510(k)-cleared medical device (K112959) manufactured by Philips Health Care. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2012. Regulation: 8.