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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 K142032
Device Name MRI PATIENT MONITORING SYSTEM TESLA M3
Applicant
Mipm Mammendorfer Institut Fur Physik Und Medizin
Prinsessegracht 20
The Hague,  NL
Applicant Contact ANDRE KINDSVATER
Correspondent
Mipm Mammendorfer Institut Fur Physik Und Medizin
Prinsessegracht 20
The Hague,  NL
Correspondent Contact ANDRE KINDSVATER
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/25/2014
Decision Date 05/07/2015
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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