510(k) K955335

DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE by Chalgren Enterprises, Inc. — Product Code IKT

K955335 is an FDA 510(k) premarket notification submitted by Chalgren Enterprises, Inc. for the device "DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE". The FDA issued a decision of Substantially Equivalent on January 29, 1996. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Chalgren Enterprises, Inc. has at least 10 other 510(k) clearances on record.