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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 K905373
Device Name MINIATURE TEMPERATURE TRAINER MODEL DT-002
Applicant
Bio-Feedback Systems, Inc.
2736 47th St.
Boulder,  CO  80301
Correspondent
Bio-Feedback Systems, Inc.
2736 47th St.
Boulder,  CO  80301
Regulation Number882.5050
Classification Product Code
HCC  
Date Received11/29/1990
Decision Date 04/10/1991
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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