
Maxtec, LLC
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ULTRAMAXO2 OXYGEN ANALYER is an FDA 510(k)-cleared medical device (K112402) manufactured by Maxtec, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2011. Regulation: 8.