Cleared Traditional

WAVEGUARD (TM) EEG CAP

K110223 · Eemagine Medical Imaging Solutions GmbH · Neurology
Jun 2011
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K110223 is an FDA 510(k) clearance for the WAVEGUARD (TM) EEG CAP, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Eemagine Medical Imaging Solutions GmbH (Naples, US). The FDA issued a Cleared decision on June 29, 2011, 155 days after receiving the submission on January 25, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K110223 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2011
Decision Date June 29, 2011
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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