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FDA 510(k)

MICROFUSE DUAL RATE INFUSER

K-Number: K091386 · 2009-10-02

Decision Date2009-10-02
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICROFUSE DUAL RATE INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Numia Medical Technology, LLC. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K091386. 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 MICROFUSE DUAL RATE INFUSER?

MICROFUSE DUAL RATE INFUSER is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is Numia Medical Technology, LLC. The 510(k) number is K091386.

When did MICROFUSE DUAL RATE INFUSER receive FDA 510(k) clearance?

MICROFUSE DUAL RATE INFUSER received FDA 510(k) clearance on 2009-10-02, under 510(k) number K091386.

Who is the listed applicant for MICROFUSE DUAL RATE INFUSER?

The FDA 510(k) record lists Numia Medical Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROFUSE DUAL RATE INFUSER?

The FDA product code for MICROFUSE DUAL RATE INFUSER is FRN.

Related Clinical Trials

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.

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.

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.

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