New Wave System

510(k) Number

K260455 ↗

FDA product code

GWQ

FDA applicant

Zeto, Inc.

Device class

Class II

Regulation

21 CFR Part 882.1400

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code GWQ (Full-Montage Standard Electroencephalograph).

• REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) by Excel Tech., Ltd.
• ELECTROENCEPHALOGRAPH by NIHON KOHDEN AMERICA, INC.
• Micromed SD LTM 64 PLUS by Micromed, Inc.
• THE VANGUARD SYSTEM by Cleveland Clinic Foundation
• SPACELABS MODEL 90480 EEG MODULE by Spacelabs, Inc.
• ELECTROENCEPHALOGRAPHS MODELS 7209, 7213 by NIHON KOHDEN AMERICA, INC.
• VIGILANT EEG MONITOR MODEL VIGILANT 2.0 by Infinite Biomedical Technologies LLC
• AMBULATORY EEG PLAYBACK by Cadwell Laboratories, Inc.
• Cadwell Apollo System by Cadwell Industries, Inc.
• micromed BRAIN QUICK by Micromed, Inc.

• Zeto TTL Extension Unit ZP-141-11011

  Class II

  FDA 510(k) K233403 Active Cleared 30 Apr 2024 GUDID on market

• Zeto Extension Unit ZP-141-11001

  Class II

  FDA 510(k) K233403 Active Cleared 30 Apr 2024 GUDID on market

• New Wave Head Unit - Small ZP-120-11051

  Class II

  FDA 510(k) K260455 Active Cleared 13 Mar 2026 GUDID on market

• New Wave Display Unit ZP-140-11021

  Class II

  FDA 510(k) K260455 Active Cleared 13 Mar 2026 GUDID on market

See all devices from Zeto Inc →