FDA 510(k)

皮下注射安全針，帶針筒的皮下注射安全針

K 號：K190183 · 2019-10-04

申請人Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

決定日期2019-10-04

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

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190183. 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 Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K190183.

When did Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe receive FDA 510(k) clearance?

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190183.

Who is the listed applicant for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

The FDA product code for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe is MEG.

其他以 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. 為申請人之記錄

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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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