NEUROAMP EEG AMPLIFIER

K974495 · Neurocorp, Ltd. · GWQ · Feb 26, 1998 · Neurology

Device Facts

• Record ID: K974495
• Device Name: NEUROAMP EEG AMPLIFIER
• Applicant: Neurocorp, Ltd.
• Product Code: GWQ · Neurology
• Decision Date: Feb 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

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 bio-electrical signals which are recorded from scalp applied electrodes, and analyzed for brain function evaluation.

Device Story

NeuroAmp EEG/EP Amplifier functions as an accessory to integrated EEG/EP systems; captures low-level bio-electrical signals via scalp-applied electrodes; amplifies signals for subsequent analysis of brain function. Used in clinical settings by trained healthcare professionals; output integrated into broader diagnostic systems for physician review. Device facilitates clinical decision-making by providing high-fidelity signal acquisition for neurological assessment.

Clinical Evidence

Bench testing only.

Technological Characteristics

EEG/EP amplifier; scalp electrode interface; signal amplification circuitry; integrated system accessory; electrical safety compliance per 21 CFR 820.

Indications for Use

Indicated for use as an accessory to integrated systems for recording and amplifying brain bio-electrical signals from scalp electrodes to facilitate brain function evaluation in patients requiring EEG/EP monitoring.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 26 1998

Mr. Emin Eralp
V.P., Technical Operations
NeuroCorp Limited
150 White Plains Road
Tarrytown, New York 10591

Re: K974495
Trade Name: NeuroAmp EEG Amplifier
Regulatory Class: II
Product Code: GWQ
Dated: November 26, 1997
Received: November 28, 1997

Dear Mr. Eralp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Eralp

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K974495

Device Name: NeuroAmp EEG/EP Amplifier:

Indications for 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 bio-electrical signals which are recorded from scalp applied electrodes, and analyzed for brain function evaluation.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974495

OR

Over-The-Counter Use

Prescription Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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