510(k) K942778

MODEL VPW2877F8, MAMMO 5 POWER SUPPLY by Varian Assoc., Inc. — Product Code IZO

K942778 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "MODEL VPW2877F8, MAMMO 5 POWER SUPPLY". The FDA issued a decision of Substantially Equivalent on July 29, 1994. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.