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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 K133419
Device Name BABYMEG BIOMAGNETOMETER SYSTEM
Applicant
Tristan Technologies, Inc.
3365 Calle Margarita
Encinitas,  CA  92024
Applicant Contact EUGENE HIRSCHKOFF
Correspondent
Tristan Technologies, Inc.
3365 Calle Margarita
Encinitas,  CA  92024
Correspondent Contact EUGENE HIRSCHKOFF
Regulation Number882.1400
Classification Product Code
OLY  
Date Received11/07/2013
Decision Date 07/21/2014
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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