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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 K872495
Device Name BIOCOMP 2001 BIOFEEDBACK DEVICE
Applicant
BIOFEEDBACK RESEARCH INSTITUTE, INC.
6399 WILSHIRE BLVD., STE.1010
LOS ANGELES,  CA  90048
Applicant Contact HERSHEL TOOMIM
Correspondent
BIOFEEDBACK RESEARCH INSTITUTE, INC.
6399 WILSHIRE BLVD., STE.1010
LOS ANGELES,  CA  90048
Correspondent Contact HERSHEL TOOMIM
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/24/1987
Decision Date 08/04/1987
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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