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FDA 510(k)

IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP

K-Number: K851447 · 1985-05-08

ApplicantY
Decision Date1985-05-08
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1985-05-08 under 510(k) number K851447. 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 IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP?

IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1985-05-08. The listed applicant is Y. The 510(k) number is K851447.

When did IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP receive FDA 510(k) clearance?

IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP received FDA 510(k) clearance on 1985-05-08, under 510(k) number K851447.

Who is the listed applicant for IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP?

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

What is the FDA product code for IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP?

The FDA product code for IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP is FRN.

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Other records listing Y as applicant

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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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