510(k) K153019

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes by Bio Protech, Inc. — Product Code GXY

K153019 is an FDA 510(k) premarket notification submitted by Bio Protech, Inc. for the device "Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes". The FDA issued a decision of Substantially Equivalent on March 21, 2016. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Bio Protech, Inc. has at least 10 other 510(k) clearances on record.