
Medicotest A/S
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DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE is an FDA 510(k)-cleared medical device (K001869) manufactured by Medicotest A/S. 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 17, 2000. Regulation: 8.