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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., NW
Walker,  MI  49534
Correspondent
Bio-Feedback Systems, Inc.
4221 Richmond Rd., NW
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
Predetermined Change
Control Plan Authorized		 No
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