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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name non-normalizing quantitative electroencephalograph software
510(k) Number K915820
Device Name NEUROSEARCH-24 OR NRS-24
Applicant
LEXICOR MEDICAL TECHNOLOGY, INC.
2585 CENTRAL AVE.
BOULDER,  CO  80301
Applicant Contact KENNETH D NICHOLS
Correspondent
LEXICOR MEDICAL TECHNOLOGY, INC.
2585 CENTRAL AVE.
BOULDER,  CO  80301
Correspondent Contact KENNETH D NICHOLS
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWQ   HCC  
Date Received12/30/1991
Decision Date 02/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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