510(k) K163109

OxyHeal 4000 Multiplace Hyperbaric Chamber Family by Oxyheal Medical Systems, Inc. — Product Code CBF

K163109 is an FDA 510(k) premarket notification submitted by Oxyheal Medical Systems, Inc. for the device "OxyHeal 4000 Multiplace Hyperbaric Chamber Family". The FDA issued a decision of Substantially Equivalent on March 22, 2017. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Oxyheal Medical Systems, Inc. has at least 1 other 510(k) clearance on record.