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510(k) K153739

MRI Patient Monitor TeslaDUO by Mipm Mammendorfer Institut Fur Physik Und Medizin — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2016
Date Received
December 28, 2015
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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