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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 K884852
Device Name BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.
Applicant
Moe
5044 Wilder Dr.
Soquel,  CA  95073
Applicant Contact MIKE WILBER
Correspondent
Moe
5044 Wilder Dr.
Soquel,  CA  95073
Correspondent Contact MIKE WILBER
Regulation Number882.5050
Classification Product Code
HCC  
Date Received11/18/1988
Decision Date 02/02/1989
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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