510(k) K062198

SUNSPOTS PRE-GELLED SURFACE ELECTRODES by Axon Systems, Inc. — Product Code GXY

K062198 is an FDA 510(k) premarket notification submitted by Axon Systems, Inc. for the device "SUNSPOTS PRE-GELLED SURFACE ELECTRODES". The FDA issued a decision of Substantially Equivalent on December 19, 2006. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Axon Systems, Inc. has at least 10 other 510(k) clearances on record.