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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 Dr.
Suite 2200
La Jolla,  CA  92037
Applicant Contact SCOTT DIENER
Correspondent
Discrete Data Systems, Inc.
8950 Villa La Jolla Dr.
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
Predetermined Change
Control Plan Authorized		 No
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