510(k) K052866

OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER by Oxyheal Health Group — Product Code CBF

K052866 is an FDA 510(k) premarket notification submitted by Oxyheal Health Group for the device "OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER". The FDA issued a decision of Substantially Equivalent on December 13, 2005. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470.