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FDA 510(k)

Dual-Safety Pen Needle

K-Number: K191853 · 2019-09-05

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2019-09-05
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Dual-Safety Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K191853. 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 Dual-Safety Pen Needle?

Dual-Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K191853.

When did Dual-Safety Pen Needle receive FDA 510(k) clearance?

Dual-Safety Pen Needle received FDA 510(k) clearance on 2019-09-05, under 510(k) number K191853.

Who is the listed applicant for Dual-Safety Pen Needle?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual-Safety Pen Needle?

The FDA product code for Dual-Safety Pen Needle is FMI.

Other records listing Promisemed Hangzhou Meditech Co., Ltd. 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.

K261196Promisemed VeriEcto Automatic Biopsy NeedlesK261045Verifine Safety LancetsK254273Verisafe Safety Sterile Needles (SSN)K250192Verisafe Safety Retractable Insulin SyringesK250961Blood collection tube holdersK251138Promisemed Safety Huber Needles

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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.

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.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., 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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