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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K153739
Device Name MRI Patient Monitor TeslaDUO
Applicant
Mipm Mammendorfer Institut Fur Physik Und Medizin
Oskar-Von-Miller-Str. 6
Mammendorf,  DE 82291
Applicant Contact HANS SCHWAIGER
Correspondent
Emergo Group
16 Congress Ave.
Suite 1400
Austin,  TX  78701
Correspondent Contact ANDRE KINDSVATER
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/28/2015
Decision Date 06/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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