Cleared Traditional

Cadwell AmpliScan

K161027 · Cadwell Industries, Inc. · Neurology

Nov 2016

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K161027 is an FDA 510(k) clearance for the Cadwell AmpliScan, a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on November 8, 2016, 210 days after receiving the submission on April 12, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K161027 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2016
Decision Date	November 08, 2016
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMA — Amplitude-integrated Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).