Cleared Traditional

CADWELL EASY WRITER AND EASY READER

K932407 · Cadwell Laboratories, Inc. · Neurology

Mar 1994

Decision

308d

Days

Class 2

Risk

About This 510(k) Submission

K932407 is an FDA 510(k) clearance for the CADWELL EASY WRITER AND EASY READER, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on March 22, 1994, 308 days after receiving the submission on May 18, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K932407 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1993
Decision Date	March 22, 1994
Days to Decision	308 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