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FDA 510(k)

MODEL 400A INFUSION PUMP

K-Number: K875348 · 1988-04-29

ApplicantAvi, Inc.
Decision Date1988-04-29
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 400A INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Avi, Inc.. It received FDA 510(k) clearance on 1988-04-29 under 510(k) number K875348. 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 MODEL 400A INFUSION PUMP?

MODEL 400A INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1988-04-29. The listed applicant is Avi, Inc.. The 510(k) number is K875348.

When did MODEL 400A INFUSION PUMP receive FDA 510(k) clearance?

MODEL 400A INFUSION PUMP received FDA 510(k) clearance on 1988-04-29, under 510(k) number K875348.

Who is the listed applicant for MODEL 400A INFUSION PUMP?

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

What is the FDA product code for MODEL 400A INFUSION PUMP?

The FDA product code for MODEL 400A INFUSION PUMP is FRN.

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Other records listing Avi, 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.

K882047ENTRUST(TM) MODEL 800K875365MODEL 200A INFUSION PUMPK875347MODEL 210A INFUSION PUMPK872514INFUSION PUMP MODEL 270K872515INFUSION PUMP MODEL 470K872516INFUSION PUMP MODEL 275

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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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