Cleared Traditional

K142099 - CUTANEOUS ELECTRODES (FDA 510(k) Clearance)

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

K142099 is an FDA 510(k) clearance for the CUTANEOUS ELECTRODES. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K142099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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