510(k) K062675

GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES by Gemore Technology Co, Ltd. — Product Code GXY

K062675 is an FDA 510(k) premarket notification submitted by Gemore Technology Co, Ltd. for the device "GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES". The FDA issued a decision of Substantially Equivalent on January 4, 2007. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Gemore Technology Co, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2007
Date Received
September 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type