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FDA 510(k)

Safety Winged Blood Collection Sets

K-Number: K211293 · 2021-06-25

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2021-06-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Winged Blood Collection Sets 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 2021-06-25 under 510(k) number K211293. 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 Safety Winged Blood Collection Sets?

Safety Winged Blood Collection Sets is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K211293.

When did Safety Winged Blood Collection Sets receive FDA 510(k) clearance?

Safety Winged Blood Collection Sets received FDA 510(k) clearance on 2021-06-25, under 510(k) number K211293.

Who is the listed applicant for Safety Winged Blood Collection Sets?

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 Safety Winged Blood Collection Sets?

The FDA product code for Safety Winged Blood Collection Sets 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.

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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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