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FDA 510(k)

INTRAVENOUS INFUSION PUMP

K-Number: K771300 · 1977-12-08

ApplicantStewart-Naumann Laboratories
Decision Date1977-12-08
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTRAVENOUS INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Stewart-Naumann Laboratories. It received FDA 510(k) clearance on 1977-12-08 under 510(k) number K771300. 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 INTRAVENOUS INFUSION PUMP?

INTRAVENOUS INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1977-12-08. The listed applicant is Stewart-Naumann Laboratories. The 510(k) number is K771300.

When did INTRAVENOUS INFUSION PUMP receive FDA 510(k) clearance?

INTRAVENOUS INFUSION PUMP received FDA 510(k) clearance on 1977-12-08, under 510(k) number K771300.

Who is the listed applicant for INTRAVENOUS INFUSION PUMP?

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

What is the FDA product code for INTRAVENOUS INFUSION PUMP?

The FDA product code for INTRAVENOUS INFUSION PUMP is FRN.

Related Clinical Trials

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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Other records listing Stewart-Naumann Laboratories 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.

K760004SYRINGE, DISPOSABLE, ALL PLASTICK760005SYRINGE, DISPOSABLE, GLASS & PLASTIC

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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