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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conditioner, Signal, Physiological
510(k) Number K860914
Device Name ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV
Applicant
Bio-Feedback Systems, Inc.
2736 47th St.
Boulder,  CO  80301
Applicant Contact JOHN PICCHIOTTINO
Correspondent
Bio-Feedback Systems, Inc.
2736 47th St.
Boulder,  CO  80301
Correspondent Contact JOHN PICCHIOTTINO
Regulation Number882.1845
Classification Product Code
GWK  
Date Received03/11/1986
Decision Date 06/06/1986
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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