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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K173749
Device Name AMRA Profiler
AMRA Medical AB
Badhusgatan 5
Linkoping,  SE 58222
Applicant Contact Janne West
Licensale Inc
68 Southwood Ter
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number892.1000
Classification Product Code
Date Received12/08/2017
Decision Date 12/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No