510(k) K974868

SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER by Perry Baromedical Corp. — Product Code CBF

K974868 is an FDA 510(k) premarket notification submitted by Perry Baromedical Corp. for the device "SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER". The FDA issued a decision of Substantially Equivalent on July 2, 1998. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Perry Baromedical Corp. has at least 2 other 510(k) clearances on record.