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FDA 510(k)

MRIDIUM 3850 MRI PUMP SYSTEM

K-Number: K050301 · 2005-03-24

ApplicantIradimed Corporation
Decision Date2005-03-24
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MRIDIUM 3850 MRI PUMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Iradimed Corporation. It received FDA 510(k) clearance on 2005-03-24 under 510(k) number K050301. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRIDIUM 3850 MRI PUMP SYSTEM?

MRIDIUM 3850 MRI PUMP SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Iradimed Corporation. The 510(k) number is K050301.

When did MRIDIUM 3850 MRI PUMP SYSTEM receive FDA 510(k) clearance?

MRIDIUM 3850 MRI PUMP SYSTEM received FDA 510(k) clearance on 2005-03-24, under 510(k) number K050301.

Who is the listed applicant for MRIDIUM 3850 MRI PUMP SYSTEM?

The FDA 510(k) record lists Iradimed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRIDIUM 3850 MRI PUMP SYSTEM?

The FDA product code for MRIDIUM 3850 MRI PUMP SYSTEM is FRN.

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Other records listing Iradimed Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242752MRidium 3870 MRI Infusion Pump System (3870)K1809033880 MRI Patient Monitoring SystemK1829003880 MRI Patient Monitoring SystemK1722003880 MRI Patient Monitoring SystemK143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemK090087MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM

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Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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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