FDA 510(k)

带安全针的 Luer 锁定注射器；可更换针头的 Luer 锁定注射器；带钝针填充的 Luer 锁定注射器

K号: K241821 · 2024-09-20

决定日期2024-09-20

产品代码FMF

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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)记录将索尔-千年医疗公司（Sol-Millennium Medical, Inc.）列为申请人。这本身并不能确立该设备的制造商。

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.

列明Sol-Millennium Medical, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252184SOL-M可更换针盘式卢埃尔锁注射器 K253110Sol-Glide安全针；带注射器的Sol-Glide安全针。K250907Sol-Guard TM XtraThin安全拉环血液采集套装。K242291SOL-M Luer Lock注射器（无针，低残留空间），SOL-M滑尖注射器（无针，低残留空间），SOL-M Luer Lock注射器（低残留空间，可更换针头），SOL-CARE Luer Lock注射器（低残留空间，带安全针），SOL-M滑尖注射器（低残留空间，可更换针头）K242099Sol-M®无针滑尖注射器，Sol-M®偏心尖无针注射器。K220713Sol-Guard自动失效注射器。

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官方来源

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