Cleared Traditional

Nihon Kohden QP-160AK EEG Trend Program

K163644 · Nihon Kohden Corporation · Neurology

May 2017

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K163644 is an FDA 510(k) clearance for the Nihon Kohden QP-160AK EEG Trend Program, a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA), submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on May 19, 2017, 147 days after receiving the submission on December 23, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K163644 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2016
Decision Date	May 19, 2017
Days to Decision	147 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).