FDA 510(k)

0.5ml Sol-Care可缩回安全注射器，带固定针

K号: K162030 · 2016-08-19

决定日期2016-08-19

产品代码MEG

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

0.5ml Sol-Care Retractable Safety Syringe with Fixed 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 2016-08-19 under 510(k) number K162030. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle?

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K162030.

When did 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle receive FDA 510(k) clearance?

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle received FDA 510(k) clearance on 2016-08-19, under 510(k) number K162030.

Who is the listed applicant for 0.5ml Sol-Care Retractable Safety Syringe with Fixed 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 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle?

The FDA product code for 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is MEG.

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。K241821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

查看所有 13 个设备 →

相关器械（代码：MEG）

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。

K252098PA3X可拆卸安全套筒注射器（带针）（SC-23ED / SD-23ED）Methyl Co., Ltd.K250847蒸汽盾Vault Paragon Group, Inc.K230287SaviSafe 安全设备Suzhou Savicred Biotechnology Co., Ltd.K231165Shina 注射器; Shina 安全注射器Shina Med Corporation K231907Medline 安全胰岛素和TB注射器Medline Industries, LP K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

官方来源

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