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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 K850759
Device Name COMPUTER INTERFACE - BIOFEEDBACK
Applicant
M.O.E Electronics Research & Prod.
419 Stanford Ave.
Santa Cruz,  CA  95062
Applicant Contact MIKE WILBER
Correspondent
M.O.E Electronics Research & Prod.
419 Stanford Ave.
Santa Cruz,  CA  95062
Correspondent Contact MIKE WILBER
Regulation Number882.5050
Classification Product Code
HCC  
Date Received02/25/1985
Decision Date 05/23/1985
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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