Cleared Traditional

REUSABLE STIMULATING ELECTRODES

K111270 · Bio Protech, Inc. · Neurology
Sep 2011
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K111270 is an FDA 510(k) clearance for the REUSABLE STIMULATING ELECTRODES, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bio Protech, Inc. (Dallas, US). The FDA issued a Cleared decision on September 13, 2011, 133 days after receiving the submission on May 3, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K111270 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2011
Decision Date September 13, 2011
Days to Decision 133 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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