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FDA 510(k)

一次性无菌針筒，帶針一次性无菌針筒

K 號：K210991 · 2021-08-26

申請人Guangdong Antmed Co., Ltd.
決定日期2021-08-26
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

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Antmed Co., Ltd.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K210991. 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 Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Guangdong Antmed Co., Ltd.. The 510(k) number is K210991.

When did Disposable Sterile Syringe, Disposable Sterile Syringe with Needle receive FDA 510(k) clearance?

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle received FDA 510(k) clearance on 2021-08-26, under 510(k) number K210991.

Who is the listed applicant for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

The FDA 510(k) record lists Guangdong Antmed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

The FDA product code for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is FMF.

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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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