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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 K942769
Device Name BIOINTEGRATOR, BIOINTEGRATOR PLUS
Applicant
BIO RESEARCH INSTITUTE
331 EAST COTATI AVE.
COSTATI,  CA  94931
Applicant Contact STEPHEN E WALL
Correspondent
BIO RESEARCH INSTITUTE
331 EAST COTATI AVE.
COSTATI,  CA  94931
Correspondent Contact STEPHEN E WALL
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/13/1994
Decision Date 09/01/1995
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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