FDA 510(k)

Luer Lock 鋼針注射器；可更換針頭的 Luer Lock 注射器；鈍頭充填針的 Luer Lock 注射器

K 號：K241821 · 2024-09-20

決定日期2024-09-20

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

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K241821. 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 Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle?

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K241821.

When did Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle receive FDA 510(k) clearance?

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle received FDA 510(k) clearance on 2024-09-20, under 510(k) number K241821.

Who is the listed applicant for Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle?

FDA 510(k) 記錄將 Sol-Millennium Medical, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle?

The FDA product code for Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle is FMF.