FDA 510(k)

単回使用の無菌皮下注射針

K番号: K211728 · 2021-10-05

申請者Jiangsu Kangyou Medical Instrument Co., Ltd.

決定日2021-10-05

製品コードFMF

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

Sterile hypodermic syringes for single use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Kangyou Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K211728. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sterile hypodermic syringes for single use?

Sterile hypodermic syringes for single use is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Jiangsu Kangyou Medical Instrument Co., Ltd.. The 510(k) number is K211728.

When did Sterile hypodermic syringes for single use receive FDA 510(k) clearance?

Sterile hypodermic syringes for single use received FDA 510(k) clearance on 2021-10-05, under 510(k) number K211728.

Who is the listed applicant for Sterile hypodermic syringes for single use?

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

What is the FDA product code for Sterile hypodermic syringes for single use?

The FDA product code for Sterile hypodermic syringes for single use is FMF.

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単回使用の無菌皮下注射針

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FMF）

公式ソース