510(k) K152223

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System by Oxyheal Medical Systems, Inc. — Product Code CBF

K152223 is an FDA 510(k) premarket notification submitted by Oxyheal Medical Systems, Inc. for the device "Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System". The FDA issued a decision of Substantially Equivalent on April 29, 2016. 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.