510(k) K952690

EMG DISC RECORDING ELECTRODE WITH PIN by Chalgren Enterprises, Inc. — Product Code GXY

K952690 is an FDA 510(k) premarket notification submitted by Chalgren Enterprises, Inc. for the device "EMG DISC RECORDING ELECTRODE WITH PIN". The FDA issued a decision of Substantially Equivalent on December 6, 1995. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Chalgren Enterprises, Inc. has at least 10 other 510(k) clearances on record.