Cleared Traditional

CADWELL EASY AMBULATORY EEG

K946094 · Cadwell Laboratories, Inc. · Neurology

Sep 1995

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K946094 is an FDA 510(k) clearance for the CADWELL EASY AMBULATORY EEG, 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 September 12, 1995, 272 days after receiving the submission on December 14, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K946094 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 1994
Decision Date	September 12, 1995
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

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