Cleared Traditional

Flexset System

K233403 · Zeto, Inc. · Neurology
Apr 2024
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K233403 is an FDA 510(k) clearance for the Flexset System, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Zeto, Inc. (Raleigh, US). The FDA issued a Cleared decision on April 30, 2024, 209 days after receiving the submission on October 4, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K233403 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2023
Decision Date April 30, 2024
Days to Decision 209 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