Compumedics Neuvo

510(k) Number

K081151 ↗

FDA product code

GWQ

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).

• 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.
• ELECTROENCEPHALOGRAPHS EEG-5208, 5210 by NIHON KOHDEN AMERICA, INC.
• 84 CHANNEL EEG by XLTEK
• DEEG-LITE by Grass-Telefactor Product Group

• Siesta 802 Basic PSG System

  Class II

  FDA 510(k) K003175 Active Cleared 27 Dec 2000 GUDID on market

• Siesta 802 Basic EEG System

  Class II

  FDA 510(k) K003175 Active Cleared 27 Dec 2000 GUDID on market

• Compumedics Summit IP

  Class II

  FDA 510(k) K040194 Active Cleared 23 Apr 2004

• Conductive EEG Electrolyte

  Class II

  FDA 510(k) K033052 Active Cleared 17 Dec 2003