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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 K211983
Device Name AMRA Profiler
Applicant
AMRA Medical AB
Badhusgatan 5
Linkoping,  SE 582 22
Applicant Contact Eric Converse
Correspondent
Arazy Group
3422 Leonardo Lane
New Smyrna Beach,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/25/2021
Decision Date 11/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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