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Viasys Neuro Care
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NICOLETONE SYSTEM V32 AMPLIFIER is an FDA 510(k)-cleared medical device (K061908) manufactured by Viasys Neuro Care. 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 5, 2006. Regulation: 8.