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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 K180903
Device Name 3880 MRI Patient Monitoring System
Applicant
Iradimed Corporation
1025 Willa Springs Dr.
Winter Springs,  FL  32708
Applicant Contact Francis X. Casey
Correspondent
Iradimed Corporation
1025 Willa Springs Dr.
Winter Springs,  FL  32708
Correspondent Contact Francis X. Casey
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/06/2018
Decision Date 03/29/2019
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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