Cleared Traditional

TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR

K042350 · Cadwell Laboratories, Inc. · Neurology
Nov 2004
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K042350 is an FDA 510(k) clearance for the TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on November 3, 2004, 65 days after receiving the submission on August 30, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K042350 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2004
Decision Date November 03, 2004
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

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