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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 K843738
Device Name CAB2 COMPUTER ASSISTED BIOFEEDBACK
Applicant
DISCRETE DATA SYSTEMS, INC.
8950 VILLA LA JOLLA DRIVE
SUITE 2200
LA JOLLA,  CA  92037 -
Applicant Contact SCOTT DIENER
Correspondent
DISCRETE DATA SYSTEMS, INC.
8950 VILLA LA JOLLA DRIVE
SUITE 2200
LA JOLLA,  CA  92037 -
Correspondent Contact SCOTT DIENER
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/25/1984
Decision Date 12/04/1984
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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