Cleared Traditional

CUTANEOUS ELECTRODES

K142099 · Bio Protech, Inc. · Neurology
Nov 2014
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K142099 is an FDA 510(k) clearance for the CUTANEOUS ELECTRODES, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bio Protech, Inc. (Wonju-Si, Gangwon-Do, KR). The FDA issued a Cleared decision on November 17, 2014, 108 days after receiving the submission on August 1, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K142099 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2014
Decision Date November 17, 2014
Days to Decision 108 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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