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Seer Home Full-Montage Standard Electroencephalograph

by Seer Medical Pty, Ltd.

510(k) K212788

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK212788 Date16 Jun 2022ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3143-2024 FDA Class II initiated 12 Aug 2024

    During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Seer Home
510(k) Number
FDA Product Code
GWQ
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Seer Home is a Full-Montage Standard Electroencephalograph (EEG), a medical device designed for continuous, long-term recording of electrical activity in the brain. It employs multiple electrodes placed on the scalp to monitor neurological function, aiding in the diagnosis and management of conditions such as epilepsy, sleep disorders, and other neurological abnormalities. The device captures high-fidelity signals to support clinical assessments in ambulatory settings, ensuring real-time or delayed analysis of brainwave patterns.

This device is intended for use in home or ambulatory settings and is supplied as a reusable system with disposable electrode components. It operates under FDA 510(k) clearance (K212788) and adheres to Class II – Special Controls regulations (product code GWQ). The system includes multiple electrode configurations (listed under registration numbers) and is designed for non-MRI environments. Storage and handling follow standard EEG device protocols, with electrode preparation requiring adherence to manufacturer guidelines for optimal signal quality and patient safety.

Questions

AI-generated answers, 20 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 types of neurological conditions is the Seer Home designed to help monitor, and how does it achieve this?

    The Seer Home is specifically designed to monitor neurological conditions such as epilepsy, sleep disorders, and other brain-related abnormalities. It achieves this by continuously recording high-fidelity electrical activity in the brain through multiple scalp electrodes. These electrodes capture brainwave patterns, enabling real-time or delayed analysis to support clinical assessments in ambulatory or home settings.

  • Is the Seer Home system reusable, and if so, what components are disposable?

    Yes, the Seer Home is supplied as a reusable system, but it includes disposable electrode components. This design allows for consistent performance of the reusable hardware while ensuring patient safety and signal quality through the use of single-use electrodes.

  • What electrode configurations are available for the Seer Home, and how do I know which one to choose?

    The Seer Home supports multiple electrode configurations, each identified by specific registration numbers (e.g., 3005550372, 3020223448, etc.). The choice of configuration depends on the clinical needs of the patient and the specific neurological assessment required. Consult the manufacturer’s guidelines or a neurologist to determine the appropriate configuration for optimal monitoring.

  • Can the Seer Home be used in an MRI environment, and what storage or handling precautions should I take?

    No, the Seer Home is explicitly designed for use in non-MRI environments. Storage and handling follow standard EEG device protocols, including proper electrode preparation and adherence to manufacturer guidelines to ensure optimal signal quality and patient safety. Avoid exposure to strong electromagnetic interference and store the device in a clean, dry environment.

  • How do I verify the regulatory compliance of the Seer Home before purchasing or using it?

    The Seer Home holds FDA 510(k) clearance (K212788) under Class II – Special Controls (product code GWQ) and is intended for neurological monitoring. To confirm compliance, check the device’s labeling for the FDA clearance number and ensure it matches the registered specifications. The manufacturer, Seer Medical Pty, Ltd., is based in Melbourne, Australia, and can provide further details on regulatory adherence.