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FDA 510(k)

3880 MRI Patient Monitoring System

K-Number: K180903 · 2019-03-29

ApplicantIradimed Corporation
Decision Date2019-03-29
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3880 MRI Patient Monitoring System is a medical device manufactured by Iradimed Corporation. It received FDA 510(k) clearance on 2019-03-29 under approval number K180903. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3880 MRI Patient Monitoring System?

3880 MRI Patient Monitoring System is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Iradimed Corporation. The 510(k) number is K180903.

When was 3880 MRI Patient Monitoring System approved by the FDA?

3880 MRI Patient Monitoring System received FDA 510(k) clearance on 2019-03-29, under approval number K180903.

What company makes 3880 MRI Patient Monitoring System?

3880 MRI Patient Monitoring System is manufactured by Iradimed Corporation.

What is the FDA product code for 3880 MRI Patient Monitoring System?

The FDA product code for 3880 MRI Patient Monitoring System is MWI.

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Related PubMed Literature

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Other Devices by Iradimed Corporation

K143369MRidium 3860+ MRI infusion Pump/ Monitoring System K1722003880 MRI Patient Monitoring System K1829003880 MRI Patient Monitoring System K242752MRidium 3870 MRI Infusion Pump System (3870)

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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