Cleared Special

New Wave System

K260455 · Zeto, Inc. · Neurology
Mar 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K260455 is an FDA 510(k) clearance for the New Wave 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 March 13, 2026, 30 days after receiving the submission on February 11, 2026. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K260455 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2026
Decision Date March 13, 2026
Days to Decision 30 days
Submission Type Special
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