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FDA 510(k)

Avoset Infusion Pump System

K-Number: K213744 · 2023-03-10

ApplicantEitan Medical , Ltd.
Decision Date2023-03-10
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Avoset Infusion Pump System is the device name listed in this FDA 510(k) record. The listed applicant is Eitan Medical , Ltd.. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K213744. 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 Avoset Infusion Pump System?

Avoset Infusion Pump System is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Eitan Medical , Ltd.. The 510(k) number is K213744.

When did Avoset Infusion Pump System receive FDA 510(k) clearance?

Avoset Infusion Pump System received FDA 510(k) clearance on 2023-03-10, under 510(k) number K213744.

Who is the listed applicant for Avoset Infusion Pump System?

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

What is the FDA product code for Avoset Infusion Pump System?

The FDA product code for Avoset Infusion Pump System is FRN.

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.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter 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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