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FDA 510(k)

HR(TM) NEEDLE AND SYRINGE

K-Number: K874372 · 1987-11-06

ApplicantIcu Medical, Inc.
Decision Date1987-11-06
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HR(TM) NEEDLE AND SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 1987-11-06 under 510(k) number K874372. 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 HR(TM) NEEDLE AND SYRINGE?

HR(TM) NEEDLE AND SYRINGE is a medical device that received FDA 510(k) clearance on 1987-11-06. The listed applicant is Icu Medical, Inc.. The 510(k) number is K874372.

When did HR(TM) NEEDLE AND SYRINGE receive FDA 510(k) clearance?

HR(TM) NEEDLE AND SYRINGE received FDA 510(k) clearance on 1987-11-06, under 510(k) number K874372.

Who is the listed applicant for HR(TM) NEEDLE AND SYRINGE?

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

What is the FDA product code for HR(TM) NEEDLE AND SYRINGE?

The FDA product code for HR(TM) NEEDLE AND SYRINGE is FMI.

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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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