Cleared Traditional

eego amplifiers

K172312 · Eemagine Medical Imaging Solutions GmbH · Neurology
Mar 2018
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K172312 is an FDA 510(k) clearance for the eego amplifiers, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Eemagine Medical Imaging Solutions GmbH (Berlin, DE). The FDA issued a Cleared decision on March 30, 2018, 241 days after receiving the submission on August 1, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K172312 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2017
Decision Date March 30, 2018
Days to Decision 241 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835