Cleared Traditional

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

K153019 · Bio Protech, Inc. · Neurology
Mar 2016
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K153019 is an FDA 510(k) clearance for the Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bio Protech, Inc. (Wonju-Si, KR). The FDA issued a Cleared decision on March 21, 2016, 158 days after receiving the submission on October 15, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K153019 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2015
Decision Date March 21, 2016
Days to Decision 158 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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