FDA 510(k)

單次使用无菌針筒

K 號：K223678 · 2023-02-09

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

決定日期2023-02-09

產品代碼FMF

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Shanghai Kindly Enterprise Development Group Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K223327无菌美學針筒及皮下針

相關器械（代碼：FMF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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