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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 K832333
Device Name FEEDBACK EMG SYSTEM PE-020
Applicant
BIO-FEEDBACK SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIO-FEEDBACK SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.5050
Classification Product Code
HCC  
Date Received07/18/1983
Decision Date 09/01/1983
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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