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Portex, Inc.
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1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX is an FDA 510(k)-cleared medical device (K014115) manufactured by Portex, 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 26, 2002. Regulation: 8.