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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 K861950
Device Name THE FM-212A BIOFEEDBACK UNIT
Applicant
Hosa Technology, Inc.
13042 Moore St.
Cerritos,  CA  90701
Applicant Contact SHOJI SATO
Correspondent
Hosa Technology, Inc.
13042 Moore St.
Cerritos,  CA  90701
Correspondent Contact SHOJI SATO
Regulation Number882.5050
Classification Product Code
HCC  
Date Received05/20/1986
Decision Date 04/22/1987
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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