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510(k) K142032

MRI PATIENT MONITORING SYSTEM TESLA M3 by Mipm Mammendorfer Institut Fur Physik Und Medizin — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2015
Date Received
July 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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