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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Galvanic Skin Response Measurement
510(k) Number K020567
Device Name AKUPORT M1
Applicant
Vibrant Health
150 Des Grands Coteaux
Beoeil, Quebec,  CA J3G 2C9
Applicant Contact STEPHEN EMOND
Correspondent
Vibrant Health
150 Des Grands Coteaux
Beoeil, Quebec,  CA J3G 2C9
Correspondent Contact STEPHEN EMOND
Regulation Number882.1540
Classification Product Code
GZO  
Date Received02/20/2002
Decision Date 05/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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