FDA 510(k)

ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE

K-Number: K895366 · 1990-05-02

Decision Date1990-05-02

Product CodeKNT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1990-05-02 under 510(k) number K895366. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE?

ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE is a medical device that received FDA 510(k) clearance on 1990-05-02. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K895366.

When did ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE receive FDA 510(k) clearance?

ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE received FDA 510(k) clearance on 1990-05-02, under 510(k) number K895366.

Who is the listed applicant for ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE?

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

What is the FDA product code for ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE?

The FDA product code for ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE is KNT.

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Other records listing Fresenius USA, Inc. as applicant

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Related Devices (Code: KNT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.