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Genexel Medical Instrument, Inc.
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FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 is an FDA 510(k)-cleared medical device (K092061) manufactured by Genexel Medical Instrument, 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 March 25, 2010. Regulation: 8.