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Oxyheal Health Group
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OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER is an FDA 510(k)-cleared medical device (K052866) manufactured by Oxyheal Health Group. 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 12, 2005. Regulation: 8.