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Bortec Biomedical, Ltd.
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ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 is an FDA 510(k)-cleared medical device (K023147) manufactured by Bortec Biomedical, Ltd.. 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 December 11, 2002. Regulation: 8.