FDA 510(k)

DRセーフティ・シリンジ、単回使用用無菌皮下注射針

K番号: K212226 · 2021-09-29

申請者Zhuhai DR Medical Instruments Co., Ltd.

決定日2021-09-29

製品コードMEG

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

DR Safety Syringe, Sterile Hypodermic needle for Single use is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K212226. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the DR Safety Syringe, Sterile Hypodermic needle for Single use?

DR Safety Syringe, Sterile Hypodermic needle for Single use is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. The 510(k) number is K212226.

When did DR Safety Syringe, Sterile Hypodermic needle for Single use receive FDA 510(k) clearance?

DR Safety Syringe, Sterile Hypodermic needle for Single use received FDA 510(k) clearance on 2021-09-29, under 510(k) number K212226.

Who is the listed applicant for DR Safety Syringe, Sterile Hypodermic needle for Single use?

The FDA 510(k) record lists Zhuhai DR Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR Safety Syringe, Sterile Hypodermic needle for Single use?

The FDA product code for DR Safety Syringe, Sterile Hypodermic needle for Single use is MEG.

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