Cleared Traditional

CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER

K962458 · Cadwell Laboratories, Inc. · Neurology
Jan 1997
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K962458 is an FDA 510(k) clearance for the CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER, 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 January 13, 1997, 202 days after receiving the submission on June 25, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K962458 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1996
Decision Date January 13, 1997
Days to Decision 202 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

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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