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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K200132
Device Name Ashvins
Applicant
MedicalCommunications GmbH
Max-Jarecki-Strasse 8
Heidelberg,  DE 69115
Applicant Contact Martin Schinkmann
Correspondent
Orasi Consulting, LLC.
1655 Forest Drive
Medina,  OH  44256
Correspondent Contact Lena Sattler
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
NFJ  
Date Received01/21/2020
Decision Date 02/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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