
Medicalgorithmics SP Z.O.O.
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MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG is an FDA 510(k)-cleared medical device (K090037) manufactured by Medicalgorithmics SP Z.O.O.. 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 21, 2009. Regulation: 8.