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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K974495
Device Name NEUROAMP EEG AMPLIFIER
Applicant
NEUROCORP, LTD.
150 WHITE PLAINS RD.
TARRYTOWN,  NY  10591
Applicant Contact EMIN ERALP
Correspondent
NEUROCORP, LTD.
150 WHITE PLAINS RD.
TARRYTOWN,  NY  10591
Correspondent Contact EMIN ERALP
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received11/28/1997
Decision Date 02/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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