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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K103782
Device Name 4D MV-ASSESSMENT 2.0
Applicant
TOMTEC IMAGING SYSTEMS, GMBH
EDISONSTRASSE 6
UNTERSCHLEISSHEIM,  DE D-85716
Applicant Contact INGE SCHEIDT
Correspondent
TOMTEC IMAGING SYSTEMS, GMBH
EDISONSTRASSE 6
UNTERSCHLEISSHEIM,  DE D-85716
Correspondent Contact INGE SCHEIDT
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/27/2010
Decision Date 01/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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