(90 days)
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.
The NeuroAmp EEG/EP amplifier is an accessory device of integrated systems used for the recording of brain bio-electrical activity.
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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 1998
Mr. Emin Eralp V.P., Technical Operations NeuroCorp Limited 150 White Plains Road Tarrytown, New York 10591
K974495 Re: NeuroAmp EEG Amplifier Trade Name: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. તે 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 requlation may result in regulatory In addition, FDA may publish further announcements ---------action. 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one regaración chorozon" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
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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510(k) Number (if known): __ K974495
Device Name: _________________________________________________________________________________________________________________________________________________________________
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 bioelectrical signals which are recorded from scalp applied electrodes, and analyzed for brain function evaluation.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K974495 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 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).