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Sensidyne, Inc.
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100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I is an FDA 510(k)-cleared medical device (K010382) manufactured by Sensidyne, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 28, 2001. Regulation: 8.