
Edx Epi-Scan, Inc.
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EPI-SCAN, MODEL P 100 is an FDA 510(k)-cleared medical device (K032935) manufactured by Edx Epi-Scan, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2003. Regulation: 8.