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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 K770663
Device Name FEEDBACK EMG SYSTEM, MODEL PE-L00
Applicant
BIO-FEEDBACK SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIO-FEEDBACK SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5050
Classification Product Code
HCC  
Date Received04/07/1977
Decision Date 04/26/1977
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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