510(k) K082455

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

K082455 is an FDA 510(k) premarket notification submitted by Gulf Coast Hyperbarics, Inc. for the device "RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER". The FDA issued a decision of Substantially Equivalent on May 22, 2009. 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.