510(k) K060739

MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 by Khrunichev State Research & Production Space Centr — Product Code CBF

K060739 is an FDA 510(k) premarket notification submitted by Khrunichev State Research & Production Space Centr for the device "MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307". The FDA issued a decision of Substantially Equivalent on July 21, 2006. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Khrunichev State Research & Production Space Centr has at least 1 other 510(k) clearance on record.