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Somnoscreen EEG10-20

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071556

by Somnomedics GmbH

Identifiers

510(k) Number
K071556 FDA 510(k)
FDA Product Code
MNR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.2375 FDA 510(k)
Regulation Number
868.2375 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Somnoscreen EEG10-20 is a portable electroencephalography (EEG) monitoring device designed for long-term recording of brain electrical activity. It adheres to the 10-20 electrode placement system, a standardized method for positioning electrodes on the scalp to measure brain waves. This device is intended for diagnostic purposes, particularly in assessing sleep disturbances and epilepsy through continuous EEG monitoring.

The Somnoscreen EEG10-20 is supplied as a reusable medical device and is classified under FDA classification II (MNR). It is intended for use in clinical settings such as neurology and anesthesiology, where continuous EEG recording is required. The device features wireless transmission and battery operation, enabling mobility and ease of use during extended monitoring sessions. No regulatory status beyond the FDA 510(k) clearance for substantial equivalence is stated in the data.

Frequently asked questions

What is the Somnoscreen EEG10-20 used for?

The Somnoscreen EEG10-20 is designed for diagnostic purposes, specifically to monitor brain electrical activity over extended periods. It adheres to the standardized 10-20 electrode placement system, making it suitable for assessing sleep disturbances and epilepsy. Clinicians use it in neurology and anesthesiology to capture continuous EEG data for accurate diagnosis and treatment planning.

Is the Somnoscreen EEG10-20 a single-use or reusable device?

The Somnoscreen EEG10-20 is classified as a reusable medical device. This means it is intended for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. Reusability helps ensure cost-effectiveness and reduces waste, though it requires adherence to strict infection control protocols to maintain patient safety.

How is the Somnoscreen EEG10-20 supplied and what are its key features?

The device is supplied as a portable, battery-operated system with wireless transmission capabilities. This design allows for mobility during long-term monitoring sessions, making it practical for use in various clinical environments. The wireless feature eliminates the need for cumbersome wiring, enhancing patient comfort and ease of use for healthcare providers.

What is the regulatory status of the Somnoscreen EEG10-20?

The Somnoscreen EEG10-20 holds an FDA 510(k) clearance, indicating it has been determined to be substantially equivalent to a legally marketed device. This clearance is based on a review by the FDA’s Anesthesiology Device Advisory Committee, ensuring it meets regulatory standards for safety and effectiveness in its intended clinical use.

Can the Somnoscreen EEG10-20 be used outside of traditional clinical settings?

While primarily intended for clinical use in neurology and anesthesiology, the portable and wireless design of the Somnoscreen EEG10-20 makes it adaptable for settings where continuous EEG monitoring is required. However, its use must comply with local regulatory guidelines and clinical protocols to ensure patient safety and data accuracy. Always consult manufacturer instructions and local healthcare regulations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SOMNOscreen™ plus - LTM - Somnomedics, Neurology - Somnomedics, SOMNOmedics Webshop

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Somnomedics GmbH

Sources (1)

  • FDA 510(k) K071556 24 fields · synced Oct 1, 2026