FDA 510(k)

針筒安全針，安全針

K 號：K193526 · 2020-07-17

決定日期2020-07-17

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

Syringe with safety needle, Safety needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K193526. 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 Syringe with safety needle, Safety needle?

Syringe with safety needle, Safety needle is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K193526.

When did Syringe with safety needle, Safety needle receive FDA 510(k) clearance?

Syringe with safety needle, Safety needle received FDA 510(k) clearance on 2020-07-17, under 510(k) number K193526.

Who is the listed applicant for Syringe with safety needle, Safety needle?

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

What is the FDA product code for Syringe with safety needle, Safety needle?

The FDA product code for Syringe with safety needle, Safety needle is FMF.

其他以 Jiangsu Caina Medical Co.,Ltd 為申請人之記錄

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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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