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FDA 510(k)

ENTERA-FLO ENTERAL FEEDING PUMP

K-Number: K894506 · 1990-08-06

ApplicantDelmed, Inc.
Decision Date1990-08-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENTERA-FLO ENTERAL FEEDING PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1990-08-06 under 510(k) number K894506. 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 ENTERA-FLO ENTERAL FEEDING PUMP?

ENTERA-FLO ENTERAL FEEDING PUMP is a medical device that received FDA 510(k) clearance on 1990-08-06. The listed applicant is Delmed, Inc.. The 510(k) number is K894506.

When did ENTERA-FLO ENTERAL FEEDING PUMP receive FDA 510(k) clearance?

ENTERA-FLO ENTERAL FEEDING PUMP received FDA 510(k) clearance on 1990-08-06, under 510(k) number K894506.

Who is the listed applicant for ENTERA-FLO ENTERAL FEEDING PUMP?

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

What is the FDA product code for ENTERA-FLO ENTERAL FEEDING PUMP?

The FDA product code for ENTERA-FLO ENTERAL FEEDING PUMP is FRN.

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Other records listing Delmed, 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.

K895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERAK895142ENTERAL PUMP SET WITH ENTERAL SPIKEK895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEK901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONK901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATIONK900106CLOSED DISCONNECT SYSTEM

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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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