510(k) K993010

BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER by Environmental Tectonics Corp. — Product Code CBF

K993010 is an FDA 510(k) premarket notification submitted by Environmental Tectonics Corp. for the device "BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER". The FDA issued a decision of Substantially Equivalent on May 30, 2000. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Environmental Tectonics Corp. has at least 2 other 510(k) clearances on record.