510(k) K973960

MODEL 37-185 by Victoreen, Inc. — Product Code LHN

K973960 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "MODEL 37-185". The FDA issued a decision of Substantially Equivalent on January 14, 1998. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Victoreen, Inc. has at least 10 other 510(k) clearances on record.