PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM

PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K852968) manufactured by Personal Computers For Medicine, 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 November 13, 1985. Regulation: 8.