
Interacoustics A/S
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INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) is an FDA 510(k)-cleared medical device (K070696) manufactured by Interacoustics A/S. 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 28, 2007. Regulation: 8.