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FDA 510(k)

MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP

K-Number: K000328 · 2000-05-09

ApplicantMedex, Inc.
Decision Date2000-05-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 2000-05-09 under 510(k) number K000328. 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 MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP?

MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2000-05-09. The listed applicant is Medex, Inc.. The 510(k) number is K000328.

When did MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP receive FDA 510(k) clearance?

MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP received FDA 510(k) clearance on 2000-05-09, under 510(k) number K000328.

Who is the listed applicant for MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP?

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

What is the FDA product code for MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP?

The FDA product code for MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP is FRN.

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Other records listing Medex, Inc. 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.

K042432PHARMGUARD TOOLBOX, MODEL G6000782K040899MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPK020780TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICPK982640MEDEX 3000 SERIES SYRINGE INFUSION PUMPK982123CONTRAST CONTROL DEVICEK955231MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP

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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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