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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 K904269
Device Name NEUROSEARCH-24 OR NRS-24
Applicant
LEXICOR MEDICAL TECHNOLOGY, INC.
2585 CENTRAL AVE.
BOULDER,  CO  80301
Applicant Contact MICHAEL HICKEY
Correspondent
LEXICOR MEDICAL TECHNOLOGY, INC.
2585 CENTRAL AVE.
BOULDER,  CO  80301
Correspondent Contact MICHAEL HICKEY
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLT  
Date Received09/18/1990
Decision Date 06/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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