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FDA 510(k)

INFUSION PUMP

K-Number: K901065 · 1990-08-21

ApplicantKendall Mcgaw Laboratories, Inc.
Decision Date1990-08-21
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Mcgaw Laboratories, Inc.. It received FDA 510(k) clearance on 1990-08-21 under 510(k) number K901065. 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 INFUSION PUMP?

INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1990-08-21. The listed applicant is Kendall Mcgaw Laboratories, Inc.. The 510(k) number is K901065.

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

INFUSION PUMP received FDA 510(k) clearance on 1990-08-21, under 510(k) number K901065.

Who is the listed applicant for INFUSION PUMP?

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

What is the FDA product code for INFUSION PUMP?

The FDA product code for INFUSION PUMP is FRN.

Related Clinical Trials

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Other records listing Kendall Mcgaw Laboratories, 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.

K905611MICRORATE PLUS INTELLIGENT PUMPK905610MICRORATE INTELLIGENT PUMPK904855ADD-A-VIALK904518VOLUMETRIC INFUSION PUMPK903809PROTECTED NEEDLE WITH OR WITHOUT IV SETK900865ADD-A-VIAL II BINARY CONNECTOR

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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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