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 ID: K172200
• 510k Number: K172200
• Device Name: 3880 MRI Patient Monitoring System
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: Iradimed Corporation 1025 Willa Springs Dr Winter Springs, FL 32708
• Contact: Francis Casey
• Correspondent: Francis Casey; Iradimed Corporation 1025 Willa Springs Dr Winter Springs, FL 32708
• Product Code: MWI
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-21
• Decision Date: 2017-10-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00856038001362	K172200	000
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00856038001775	K172200	000