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FDA 510(k)

TFV-2300 INFUSION PUMP

K-Number: K890736 · 1990-07-09

ApplicantNihon Kohden America, Inc.
Decision Date1990-07-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TFV-2300 INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1990-07-09 under 510(k) number K890736. 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 TFV-2300 INFUSION PUMP?

TFV-2300 INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1990-07-09. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K890736.

When did TFV-2300 INFUSION PUMP receive FDA 510(k) clearance?

TFV-2300 INFUSION PUMP received FDA 510(k) clearance on 1990-07-09, under 510(k) number K890736.

Who is the listed applicant for TFV-2300 INFUSION PUMP?

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

What is the FDA product code for TFV-2300 INFUSION PUMP?

The FDA product code for TFV-2300 INFUSION PUMP is FRN.

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Other records listing Nihon Kohden America, 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

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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