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Compumedics E-Series EEG System

by Compumedics Neuro Science Pty, Ltd.

510(k) K000068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000068 Date13 Mar 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0652-05 FDA Unclassified (pre-2012) initiated 24 Feb 2005 on shared 510(k) K000068

    Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLT
FDA applicant
Compumedics Neuro Science Pty , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Compumedics E-Series EEG System is a Non-Normalizing Quantitative Electroencephalograph Software designed for digital electroencephalography (EEG) monitoring, sleep studies, and synchronous video/data recording. It provides real-time brainwave analysis, enabling clinical assessment of neurological activity, seizure detection, and sleep architecture evaluation. The system integrates hardware and software components to deliver continuous EEG monitoring with advanced signal processing capabilities.

This system is intended for use in clinical and research settings, including critical care units, neurology departments, and sleep laboratories. Supplied as a reusable, non-sterile medical device, it operates within Class II regulatory classification under FDA 510(k) clearance (K000068). Multiple software versions (identified by FEI numbers) are authorized for use, ensuring compatibility with various EEG monitoring applications. Storage and handling follow standard medical device protocols, with no specific MRI safety restrictions noted.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Compumedics E-Series EEG System used for?

    The Compumedics E-Series EEG System is designed for digital electroencephalography (EEG) monitoring, sleep studies, and synchronous video/data recording. It provides real-time brainwave analysis to assess neurological activity, detect seizures, and evaluate sleep architecture. This makes it ideal for clinical and research settings, including critical care units, neurology departments, and sleep laboratories.

  • How is the Compumedics E-Series EEG System supplied and what are its sterility and reuse details?

    The system is supplied as a reusable, non-sterile medical device. It is intended for repeated use in clinical environments, adhering to standard medical device handling protocols. Sterility is not applicable as it is not a single-use or sterile device, but proper cleaning and maintenance are required to ensure reliable performance and infection control.

  • Does the Compumedics E-Series EEG System have multiple software versions, and how are they identified?

    Yes, the Compumedics E-Series EEG System supports multiple software versions, each identified by a unique FEI (Final Equipment Identification) number. These versions ensure compatibility with various EEG monitoring applications, including different clinical and research needs. The system is designed to accommodate these variations while maintaining functionality.

  • Are there any specific storage or handling requirements for the Compumedics E-Series EEG System?

    The system follows standard medical device protocols for storage and handling. While no specific MRI safety restrictions are noted, it should be stored in a clean, dry environment to prevent damage or contamination. Proper maintenance and calibration are essential to ensure accurate and reliable performance over time.

  • What regulatory pathway does the Compumedics E-Series EEG System follow?

    The Compumedics E-Series EEG System is classified as a Class II medical device and has received FDA 510(k) clearance under the traditional pathway. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended use.