FDA 510(k)

単回使用用無菌注射器（針付き/付きなし）

K番号: K210227 · 2021-09-10

申請者Zhejiang Kangkang Medical-Devices Co., Ltd.

決定日2021-09-10

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 syringe for single use with/without needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K210227. 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 syringe for single use with/without needle?

Sterile syringe for single use with/without needle is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210227.

When did Sterile syringe for single use with/without needle receive FDA 510(k) clearance?

Sterile syringe for single use with/without needle received FDA 510(k) clearance on 2021-09-10, under 510(k) number K210227.

Who is the listed applicant for Sterile syringe for single use with/without needle?

The FDA 510(k) record lists Zhejiang Kangkang Medical-Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile syringe for single use with/without needle?

The FDA product code for Sterile syringe for single use with/without needle is FMF.

申請者としてZhejiang Kangkang Medical-Devices Co., Ltd.を記載するその他の記録

K213535無菌安全性皮下注射針（単回使用）K210229無菌自動停止注射器（針付き/針なし、単回使用用）K210232単回使用用無菌皮下注射針

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