Cleared Traditional

PROTENS ELECTRODE

K042301 · Bio Protech, Inc. · Neurology
Sep 2004
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K042301 is an FDA 510(k) clearance for the PROTENS ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bio Protech, Inc. (Crofton, US). The FDA issued a Cleared decision on September 3, 2004, 9 days after receiving the submission on August 25, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K042301 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2004
Decision Date September 03, 2004
Days to Decision 9 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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