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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, biofeedback
510(k) Number K961718
Device Name DEI MODEL 20 EEG
Applicant
DISCOVERY ENGINEERING INTL., INC.
3115 WESTWOOD DR.
TOPEKA,  KS  66614 -2741
Applicant Contact REX HARTZELL
Correspondent
DISCOVERY ENGINEERING INTL., INC.
3115 WESTWOOD DR.
TOPEKA,  KS  66614 -2741
Correspondent Contact REX HARTZELL
Regulation Number882.5050
Classification Product Code
HCC  
Date Received05/02/1996
Decision Date 08/27/1996
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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