510(k) K231167

Conductive Silicone Rubber Electrode by Guangzhou Xinbo Electronic Co., Ltd. — Product Code GXY

K231167 is an FDA 510(k) premarket notification submitted by Guangzhou Xinbo Electronic Co., Ltd. for the device "Conductive Silicone Rubber Electrode". The FDA issued a decision of Substantially Equivalent on August 9, 2023. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Guangzhou Xinbo Electronic Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2023
Date Received
April 25, 2023
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