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Electroencephalograph (EEG)

by Moberg Medical, Inc.

510(k) K960170

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK960170 Date1 Mar 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
GWF
Device Class
Class II
Regulation
21 CFR Part 882.1870
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Electroencephalograph (EEG) is a diagnostic device used to record electrical activity in the brain. It measures and displays brain wave patterns to aid in the evaluation of neurological function, seizure disorders, sleep disorders, and other brain-related conditions.

This device is intended for use in clinical settings such as hospitals and neurology clinics. It is supplied as a reusable medical instrument and is classified under FDA regulations as a Class II device. The EEG system is designed for non-invasive monitoring and does not require MRI safety considerations. It operates based on the principles of electrophysiology and is authorized under the FDA 510(k) clearance (K960170) for substantial equivalence in neurological applications.

Other devices from Moberg Medical, Inc.

  • Neurotrac II

    Class II

Questions

AI-generated answers, 19 Sep 2026

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

  • What clinical conditions is this EEG device primarily used to evaluate?

    This EEG device is designed to record and analyze brain wave patterns to aid in the evaluation of neurological function, seizure disorders, and sleep disorders. It helps clinicians diagnose and monitor conditions related to brain activity by providing visual representations of electrical signals generated by the brain.

  • Is this EEG device reusable or single-use, and what does that mean for maintenance?

    This EEG device is supplied as a reusable medical instrument, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. Reusability requires adherence to strict infection control protocols to ensure safety and functionality between uses, typically involving sterilization or high-level disinfection as per clinical guidelines.

  • What types of clinical settings is this EEG device intended for, and does it require any special safety considerations?

    This EEG device is intended for use in clinical settings such as hospitals and neurology clinics. It is designed for non-invasive monitoring and does not require MRI safety considerations, meaning it can be safely used in environments where MRI machines are present without interference or risk.

  • How was the regulatory pathway for this EEG device determined, and what does that imply for its use?

    This EEG device was authorized through the FDA’s 510(k) clearance process, specifically under the Traditional pathway, and was determined to be substantially equivalent to a predicate device. This implies that the device meets FDA standards for safety and effectiveness in neurological applications, as reviewed by the Neurology Advisory Committee, and is classified as a Class II device under FDA regulations.