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Neuro Therm, Inc.
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NT 2000 LESIONING GENERATOR is an FDA 510(k)-cleared medical device (K111576) manufactured by Neuro Therm, 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 September 19, 2011. Regulation: 8.