Cleared Traditional

CADWELL FLEX EEG/PSG

K133355 · Cadwell Industries, Inc. · Neurology

Jan 2014

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K133355 is an FDA 510(k) clearance for the CADWELL FLEX EEG/PSG, 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 January 29, 2014, 90 days after receiving the submission on October 31, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K133355 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2013
Decision Date	January 29, 2014
Days to Decision	90 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