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510(k) K180903

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2019
Date Received
April 6, 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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  • K143369 — MRidium 3860+ MRI infusion Pump/ Monitoring System (December 15, 2016)
  • K090087 — MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM (April 7, 2009)
  • K050301 — MRIDIUM 3850 MRI PUMP SYSTEM (March 24, 2005)

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