Cleared Traditional

Cadwell Zenith System

K181466 · Cadwell Industries, Inc. · Neurology

Sep 2018

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K181466 is an FDA 510(k) clearance for the Cadwell Zenith System, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on September 1, 2018, 89 days after receiving the submission on June 4, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K181466 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2018
Decision Date	September 01, 2018
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWQ — Full-montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations