Cleared Traditional

WR19 System

K172735 · Zeto, Inc. · Neurology

Apr 2018

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K172735 is an FDA 510(k) clearance for the WR19 System, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Zeto, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 17, 2018, 218 days after receiving the submission on September 11, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K172735 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2017
Decision Date	April 17, 2018
Days to Decision	218 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