510(k) K942100

MODEL TM EP HIGH VOLTAGE GENERATOR by Continental X-Ray Corp. — Product Code IZO

K942100 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "MODEL TM EP HIGH VOLTAGE GENERATOR". The FDA issued a decision of Substantially Equivalent on June 7, 1994. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.