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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, depth
510(k) Number K991077
Device Name MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
Applicant
MICRORECORDING SYSTEMS CONSULTANTS, LLC.
2842 E. FOOTHILL BLVD.
PASADENA,  CA  91107
Applicant Contact ROBERT L ROGERS
Correspondent
MICRORECORDING SYSTEMS CONSULTANTS, LLC.
2842 E. FOOTHILL BLVD.
PASADENA,  CA  91107
Correspondent Contact ROBERT L ROGERS
Regulation Number882.1330
Classification Product Code
GZL  
Subsequent Product Codes
GWL   GWQ   MNR  
Date Received03/31/1999
Decision Date 06/09/1999
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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