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Olympus Winter & Ibe GmbH
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OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 is an FDA 510(k)-cleared medical device (K020507) manufactured by Olympus Winter & Ibe GmbH. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2002. Regulation: 8.