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Recom Managed Systems, Inc.
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RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 is an FDA 510(k)-cleared medical device (K032882) manufactured by Recom Managed 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 January 27, 2004. Regulation: 8.