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FDA 510(k)

ENTECH ENTERAL PUMP AND SET

K-Number: K873444 · 1987-11-02

ApplicantEntech, Inc.
Decision Date1987-11-02
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENTECH ENTERAL PUMP AND SET is the device name listed in this FDA 510(k) record. The listed applicant is Entech, Inc.. It received FDA 510(k) clearance on 1987-11-02 under 510(k) number K873444. 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 ENTECH ENTERAL PUMP AND SET?

ENTECH ENTERAL PUMP AND SET is a medical device that received FDA 510(k) clearance on 1987-11-02. The listed applicant is Entech, Inc.. The 510(k) number is K873444.

When did ENTECH ENTERAL PUMP AND SET receive FDA 510(k) clearance?

ENTECH ENTERAL PUMP AND SET received FDA 510(k) clearance on 1987-11-02, under 510(k) number K873444.

Who is the listed applicant for ENTECH ENTERAL PUMP AND SET?

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

What is the FDA product code for ENTECH ENTERAL PUMP AND SET?

The FDA product code for ENTECH ENTERAL PUMP AND SET is FRN.

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Other records listing Entech, 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.

K891371GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFGK890430ENTAINER(TM) ENTERAL FEEDING CONTAINERK873343ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEMK871019ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SETK861427ENTUBE TM, ENTERAL FEEDING TUBEK861552TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS

View all 7 devices →

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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