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FDA 510(k)

INFUSET W/HUBER NEEDLE

K-Number: K844313 · 1985-01-22

ApplicantMed Fusion Systems, Inc.
Decision Date1985-01-22
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSET W/HUBER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Med Fusion Systems, Inc.. It received FDA 510(k) clearance on 1985-01-22 under 510(k) number K844313. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSET W/HUBER NEEDLE?

INFUSET W/HUBER NEEDLE is a medical device that received FDA 510(k) clearance on 1985-01-22. The listed applicant is Med Fusion Systems, Inc.. The 510(k) number is K844313.

When did INFUSET W/HUBER NEEDLE receive FDA 510(k) clearance?

INFUSET W/HUBER NEEDLE received FDA 510(k) clearance on 1985-01-22, under 510(k) number K844313.

Who is the listed applicant for INFUSET W/HUBER NEEDLE?

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

What is the FDA product code for INFUSET W/HUBER NEEDLE?

The FDA product code for INFUSET W/HUBER NEEDLE is FMI.

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Other records listing Med Fusion Systems, 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.

K873961INFUMED 300 AMBULATORY INFUSION PUMPK870524AMBULATORY INFUSION PUMP DRUG RESERVOIRK870907INTRODUCER, PERCUTANEOUSK864407REFILLABLE SYRINGEK863814BAG SPIKE EXTENSION SETK860616VOLUME CONTROL SET WITH EXTENSION

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Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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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