
Encision, Inc.
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EM3 AEM MONITOR AEM CONNECTORS is an FDA 510(k)-cleared medical device (K122383) manufactured by Encision, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2013. Regulation: 8.