DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE

DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE is an FDA 510(k)-cleared medical device (K955335) manufactured by Chalgren Enterprises, Inc.. 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 January 28, 1996. Regulation: 8.