FDA 510(k)

単回使用用無菌注射器

K番号: K223678 · 2023-02-09

申請者Shanghai Kindly Enterprise Development Group Co., Ltd.

決定日2023-02-09

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 Syringes for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Kindly Enterprise Development Group Co., Ltd.. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K223678. 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 Syringes for Single Use?

Sterile Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Shanghai Kindly Enterprise Development Group Co., Ltd.. The 510(k) number is K223678.

When did Sterile Syringes for Single Use receive FDA 510(k) clearance?

Sterile Syringes for Single Use received FDA 510(k) clearance on 2023-02-09, under 510(k) number K223678.

Who is the listed applicant for Sterile Syringes for Single Use?

The FDA 510(k) record lists Shanghai Kindly Enterprise Development Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Syringes for Single Use?

The FDA product code for Sterile Syringes for Single Use is FMF.

申請者としてShanghai Kindly Enterprise Development Group Co., Ltd.を記載するその他の記録

K223327無菌美学カニューレおよび皮下注射針

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