FDA 510(k)

單次使用无菌皮下注射安全針

K 號：K163162 · 2017-03-20

申請人Jiangxi Hongda Medical Equipment Group , Ltd.

決定日期2017-03-20

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 Hypodermic Safety Syringes for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163162. 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 Hypodermic Safety Syringes for Single Use?

Sterile Hypodermic Safety Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163162.

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

Sterile Hypodermic Safety Syringes for Single Use received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163162.

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

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Sterile Hypodermic Safety Syringes for Single Use is MEG.

其他以 Jiangxi Hongda Medical Equipment Group , 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。

K211753無菌針筒，配安全針 K210578醫用尼龍檢查手套（無電力，藍色）K210821醫療用PVC檢查手套 K163160無菌單次使用輸液套管 K163161無菌一次性針筒

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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