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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 K990538
Device Name BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
Applicant
BRAINMASTER
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
BRAINMASTER
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number882.5050
Classification Product Code
HCC  
Subsequent Product Code
GWQ  
Date Received02/19/1999
Decision Date 05/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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