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Fischer-Zoth Audiologic Systems, Inc.
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ECHO-SCREEN T, TA, TD, TDA, TC is an FDA 510(k)-cleared medical device (K013977) manufactured by Fischer-Zoth Audiologic Systems, 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 June 13, 2002. Regulation: 8.