FDA 510(k)

DISENTRONIC PENFINE INJECTION PEN NEEDLE

K-Number: K994197 · 1999-12-29

Decision Date1999-12-29

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DISENTRONIC PENFINE INJECTION PEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Disetronic Medical Systems. It received FDA 510(k) clearance on 1999-12-29 under 510(k) number K994197. 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 DISENTRONIC PENFINE INJECTION PEN NEEDLE?

DISENTRONIC PENFINE INJECTION PEN NEEDLE is a medical device that received FDA 510(k) clearance on 1999-12-29. The listed applicant is Disetronic Medical Systems. The 510(k) number is K994197.

When did DISENTRONIC PENFINE INJECTION PEN NEEDLE receive FDA 510(k) clearance?

DISENTRONIC PENFINE INJECTION PEN NEEDLE received FDA 510(k) clearance on 1999-12-29, under 510(k) number K994197.

Who is the listed applicant for DISENTRONIC PENFINE INJECTION PEN NEEDLE?

The FDA 510(k) record lists Disetronic Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISENTRONIC PENFINE INJECTION PEN NEEDLE?

The FDA product code for DISENTRONIC PENFINE INJECTION PEN NEEDLE is FMI.

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Other records listing Disetronic Medical Systems as applicant

K013782DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE K994186DISETRONIC D-TRON INSULIN INFUSION PUMP K993666DISETRONIC PEN P100 K991376DAHEDI INSULIN INFUSION PUMP K990259DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM K982966DISETRONIC PEN

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Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed 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

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