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510(k) K182900

3880 MRI Patient Monitoring System by Iradimed Corporation — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2018
Date Received
October 16, 2018
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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