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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
Applicant Contact REX HARTZELL
Correspondent
Discovery Engineering Intl., Inc.
3115 Westwood Dr.
Topeka,  KS  66614
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
Predetermined Change
Control Plan Authorized		 No
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