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FDA 510(k)

SE INFUSION SYSTEM WITH MMS

K-Number: K043590 · 2005-03-25

ApplicantCardinal Health, Alaris Products
Decision Date2005-03-25
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SE INFUSION SYSTEM WITH MMS is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Alaris Products. It received FDA 510(k) clearance on 2005-03-25 under 510(k) number K043590. 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 SE INFUSION SYSTEM WITH MMS?

SE INFUSION SYSTEM WITH MMS is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Cardinal Health, Alaris Products. The 510(k) number is K043590.

When did SE INFUSION SYSTEM WITH MMS receive FDA 510(k) clearance?

SE INFUSION SYSTEM WITH MMS received FDA 510(k) clearance on 2005-03-25, under 510(k) number K043590.

Who is the listed applicant for SE INFUSION SYSTEM WITH MMS?

The FDA 510(k) record lists Cardinal Health, Alaris Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SE INFUSION SYSTEM WITH MMS?

The FDA product code for SE INFUSION SYSTEM WITH MMS is FRN.

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Other records listing Cardinal Health, Alaris Products 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.

K071400SMARTSITE STOPCOCKK071108TEXIUM SYRINGEK061285SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETSK053049ALARIS SAFETY MALE LUERK052790SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBDK051641ALARIS SYSTEM PC UNIT, MODEL 8001

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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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