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FDA 510(k)

SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X

K-Number: K070268 · 2007-02-23

ApplicantCardinal Health 303,Inc.
Decision Date2007-02-23
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health 303,Inc.. It received FDA 510(k) clearance on 2007-02-23 under 510(k) number K070268. 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 SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X?

SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X is a medical device that received FDA 510(k) clearance on 2007-02-23. The listed applicant is Cardinal Health 303,Inc.. The 510(k) number is K070268.

When did SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X receive FDA 510(k) clearance?

SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X received FDA 510(k) clearance on 2007-02-23, under 510(k) number K070268.

Who is the listed applicant for SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X?

The FDA 510(k) record lists Cardinal Health 303,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X?

The FDA product code for SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X is FRN.

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Other records listing Cardinal Health 303,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.

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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

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

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