510(k) K923584

THERAPAX DXT 300 SERIES 3 by Oldelft Corp. of America — Product Code JAD

K923584 is an FDA 510(k) premarket notification submitted by Oldelft Corp. of America for the device "THERAPAX DXT 300 SERIES 3". The FDA issued a decision of Substantially Equivalent on January 15, 1993. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Oldelft Corp. of America has at least 8 other 510(k) clearances on record.