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Neurotronics, Inc.
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POLYSMITH SLEEP SYSTEM, MODEL NTI5498 is an FDA 510(k)-cleared medical device (K062943) manufactured by Neurotronics, 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 May 8, 2007. Regulation: 8.