
Gn Otometrics A/S
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FOCUS VNG/ENG TYPE 1068 is an FDA 510(k)-cleared medical device (K061791) manufactured by Gn Otometrics 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 July 10, 2006. Regulation: 8.