Cleared Traditional

Cadwell Apollo System

K180269 · Cadwell Industries, Inc. · Neurology

Jul 2018

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K180269 is an FDA 510(k) clearance for the Cadwell Apollo 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 July 17, 2018, 167 days after receiving the submission on January 31, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K180269 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2018
Decision Date	July 17, 2018
Days to Decision	167 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