3880 MRI Patient Monitoring System

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Iradimed Corporation

The following data is part of a premarket notification filed by Iradimed Corporation with the FDA for 3880 Mri Patient Monitoring System.

Pre-market Notification Details

Device IDK182900
510k NumberK182900
Device Name:3880 MRI Patient Monitoring System
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Iradimed Corporation 1025 Willa Springs Dr Winter Springs,  FL  32708
ContactFrancis X. Casey
CorrespondentFrancis X. Casey
Iradimed Corporation 1025 Willa Springs Dr Winter Springs,  FL  32708
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-16
Decision Date2018-12-14
Summary:summary

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