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Palco Labs, Inc.
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MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 is an FDA 510(k)-cleared medical device (K002787) manufactured by Palco Labs, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2000. Regulation: 8.