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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Magnetoencephalograph
510(k) Number K152184
Device Name MagView BIOMAGNETOMETER SYSTEM
Applicant
Tristan Technologies, Inc.
6191 Cornerstone Ct., Suite 107
San Diego,  CA  92121
Applicant Contact KEVIN PRATT
Correspondent
Eugene Hirschkoff, Consultant
3365 Calle Margarita
Encinitas,  CA  92024
Correspondent Contact EUGENE HIRSCHKOFF
Regulation Number882.1400
Classification Product Code
OLY  
Date Received08/05/2015
Decision Date 04/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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