Snap EEG Monitor

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

510(k) Number

K020218 ↗

FDA Product Code

OLW

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Nicolet Biomedical, Inc. →

• What is the SNAP EEG Monitor primarily used for in clinical settings?

  The SNAP EEG Monitor is designed to acquire, process, and display electroencephalogram (EEG) signals, generating a SNAP Index to quantify brain activity levels. This aids clinicians in neurological assessments, particularly in evaluating brain function and activity patterns during monitoring.

• Is the SNAP EEG Monitor a reusable device, and what components are included in its supply?

  Yes, the SNAP EEG Monitor itself is a reusable medical device. Its supply includes a Visor SNAP module for handheld integration, single-patient-use disposable electrodes, patient cables, and Windows-based PC software for processing and displaying EEG data.

• How is the regulatory status of the SNAP EEG Monitor determined, and what pathway was used for its clearance?

  The SNAP EEG Monitor received FDA 510(k) clearance under the Abbreviated review pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This classification is based on its intended use as an index-generating electroencephalograph software system.

• What medical specialty is the SNAP EEG Monitor primarily associated with, and where is it typically used?

  The SNAP EEG Monitor is primarily associated with the medical specialty of neurology and is designed for use in clinical neurology settings. It is intended for neurological assessments where continuous or periodic monitoring of brain activity is required.

• Are there any specific storage or handling instructions mentioned for the SNAP EEG Monitor?

  The provided data does not specify any storage or handling instructions for the SNAP EEG Monitor itself, but since it is a reusable device, proper care should be taken to maintain its functionality, including cleaning and calibration as recommended by the manufacturer. The single-use disposable electrodes would require adherence to standard sterile handling practices.