510(k) K950957

MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM by Gulf Coast Hyperbarics, Inc. — Product Code CBF

K950957 is an FDA 510(k) premarket notification submitted by Gulf Coast Hyperbarics, Inc. for the device "MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM". The FDA issued a decision of Substantially Equivalent on June 2, 1995. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Gulf Coast Hyperbarics, Inc. has at least 2 other 510(k) clearances on record.