Cleared Traditional

Neo

K192889 · Eemagine Medical Imaging Solutions GmbH · Neurology

Jan 2020

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K192889 is an FDA 510(k) clearance for the Neo, a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA), submitted by Eemagine Medical Imaging Solutions GmbH (Berlin, DE). The FDA issued a Cleared decision on January 30, 2020, 112 days after receiving the submission on October 10, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K192889 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2019
Decision Date	January 30, 2020
Days to Decision	112 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).