FDA 510(k)

単回使用用の無菌注射器（針付き/針なし）

K番号: K231729 · 2023-09-08

決定日2023-09-08

製品コードFMI

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 with/without needle is the device name listed in this FDA 510(k) record. The listed applicant is Wepon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231729. The device is classified under product code FMI. 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 with/without needle?

Sterile syringes for single use with/without needle is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Wepon Medical Technology Co., Ltd.. The 510(k) number is K231729.

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

Sterile syringes for single use with/without needle received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231729.

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

The FDA 510(k) record lists Wepon Medical Technology 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 with/without needle?

The FDA product code for Sterile syringes for single use with/without needle is FMI.

申請者としてWepon Medical Technology Co., Ltd.を記載するその他の記録

K231723無菌安全性皮下注射針（単回使用）K231727無菌自動停止注射器（針付き/針なし、単回使用用）K231720単回使用用無菌皮下注射針 K212299医療用外科マスク

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