FDA 510(k)

DR安全針筒，无菌一次性皮下針

K 號：K212226 · 2021-09-29

申請人Zhuhai DR Medical Instruments Co., Ltd.

決定日期2021-09-29

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

DR Safety Syringe, Sterile Hypodermic needle for Single use is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K212226. 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 DR Safety Syringe, Sterile Hypodermic needle for Single use?

DR Safety Syringe, Sterile Hypodermic needle for Single use is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. The 510(k) number is K212226.

When did DR Safety Syringe, Sterile Hypodermic needle for Single use receive FDA 510(k) clearance?

DR Safety Syringe, Sterile Hypodermic needle for Single use received FDA 510(k) clearance on 2021-09-29, under 510(k) number K212226.

Who is the listed applicant for DR Safety Syringe, Sterile Hypodermic needle for Single use?

The FDA 510(k) record lists Zhuhai DR Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR Safety Syringe, Sterile Hypodermic needle for Single use?

The FDA product code for DR Safety Syringe, Sterile Hypodermic needle for Single use is MEG.

其他以 Zhuhai DR Medical Instruments Co., Ltd. 為申請人之記錄

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K251788延伸管

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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