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FDA 510(k)

FLEXIFLO QUANTUM ENTERAL PUMP

K-Number: K944669 · 1995-07-24

ApplicantAbbott Mfg., Inc.
Decision Date1995-07-24
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLEXIFLO QUANTUM ENTERAL PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Mfg., Inc.. It received FDA 510(k) clearance on 1995-07-24 under 510(k) number K944669. 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 FLEXIFLO QUANTUM ENTERAL PUMP?

FLEXIFLO QUANTUM ENTERAL PUMP is a medical device that received FDA 510(k) clearance on 1995-07-24. The listed applicant is Abbott Mfg., Inc.. The 510(k) number is K944669.

When did FLEXIFLO QUANTUM ENTERAL PUMP receive FDA 510(k) clearance?

FLEXIFLO QUANTUM ENTERAL PUMP received FDA 510(k) clearance on 1995-07-24, under 510(k) number K944669.

Who is the listed applicant for FLEXIFLO QUANTUM ENTERAL PUMP?

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

What is the FDA product code for FLEXIFLO QUANTUM ENTERAL PUMP?

The FDA product code for FLEXIFLO QUANTUM ENTERAL PUMP is FRN.

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Other records listing Abbott Mfg., 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.

K981457ALBPK981232CAK981231CO2K965230ABBOTT LIFECARE STANDARD TUBING INFUSION PUMPK971293LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVEK953656ABBOTT IMX PROLACTIN(MODIFICATION)

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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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