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K Number
K974495
Device Name
NEUROAMP EEG AMPLIFIER
Manufacturer
NEUROCORP, LTD.
Date Cleared
1998-02-26

(90 days)

Product Code
GWQ
Regulation Number
882.1400
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NeuroAmp EEG/EP amplifier is an accessory device of integrated systems used for the recording of brain bio-electrical activity. It intended use is for the amplification of brain bioelectrical signals which are recorded from scalp applied electrodes, and analyzed for brain function evaluation.

Device Description

The NeuroAmp EEG/EP amplifier is an accessory device of integrated systems used for the recording of brain bio-electrical activity.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance results of the NeuroAmp EEG Amplifier. The document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to a predicate device and can be marketed. It outlines regulatory information but does not include a scientific study's details.

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).