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Epi Mobile Health Solutions (S) Pte, Ltd.
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EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) is an FDA 510(k)-cleared medical device (K121628) manufactured by Epi Mobile Health Solutions (S) Pte, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 2013. Regulation: 8.