Cleared Traditional

Micromed BRAIN QUICK system

K171384 · Micromed S.P.A. · Neurology

Feb 2018

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K171384 is an FDA 510(k) clearance for the Micromed BRAIN QUICK system, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Micromed S.P.A. (Mogliano Veneto, IT). The FDA issued a Cleared decision on February 1, 2018, 266 days after receiving the submission on May 11, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K171384 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2017
Decision Date	February 01, 2018
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWQ — Full-montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations