510(k) K870851

EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR by Electromed Intl., Ltd. — Product Code IZO

K870851 is an FDA 510(k) premarket notification submitted by Electromed Intl., Ltd. for the device "EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on March 20, 1987. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Electromed Intl., Ltd. has at least 10 other 510(k) clearances on record.