FDA 510(k)

美林確鎖安全針，美林確鎖安全針筒

K 號：K213054 · 2022-12-09

決定日期2022-12-09

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

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K213054. 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 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Medline Industries, Inc.. The 510(k) number is K213054.

When did Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe receive FDA 510(k) clearance?

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe received FDA 510(k) clearance on 2022-12-09, under 510(k) number K213054.

Who is the listed applicant for Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

The FDA product code for Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is FMF.

其他以 Medline Industries, Inc. 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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官方來源

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