FDA 510(k)

无菌單次使用固定安全針注射器

K 號：K212652 · 2022-03-02

決定日期2022-03-02

產品代碼MEG

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 Syringe with Fixed Safety Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K212652. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Syringe with Fixed Safety Needle for Single Use?

Sterile Syringe with Fixed Safety Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Gemtier Medical (Shanghai), Inc.. The 510(k) number is K212652.

When did Sterile Syringe with Fixed Safety Needle for Single Use receive FDA 510(k) clearance?

Sterile Syringe with Fixed Safety Needle for Single Use received FDA 510(k) clearance on 2022-03-02, under 510(k) number K212652.

Who is the listed applicant for Sterile Syringe with Fixed Safety Needle for Single Use?

The FDA 510(k) record lists Gemtier Medical (Shanghai), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Syringe with Fixed Safety Needle for Single Use?

The FDA product code for Sterile Syringe with Fixed Safety Needle for Single Use is MEG.

其他以 Gemtier Medical (Shanghai), Inc. 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。

K202493醫用口罩 K202331醫用口罩 K192679无菌單次使用保護針注射器，單次使用无菌注射器，單次使用无菌保護針 K170276單次使用安全血液收集設備

相關器械（代碼：MEG）

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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