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Oktx, LLC
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PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) is an FDA 510(k)-cleared medical device (K123902) manufactured by Oktx, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 12, 2013. Regulation: 8.