FDA 510(k)

SCIg60 注射器

K号: K161906 · 2016-12-01

决定日期2016-12-01

产品代码PKP

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决定实质等同

器械摘要

SCIg60 Infuser is the device name listed in this FDA 510(k) record. The listed applicant is Emed Technologies Corporation. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K161906. The device is classified under product code PKP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SCIg60 Infuser?

SCIg60 Infuser is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Emed Technologies Corporation. The 510(k) number is K161906.

When did SCIg60 Infuser receive FDA 510(k) clearance?

SCIg60 Infuser received FDA 510(k) clearance on 2016-12-01, under 510(k) number K161906.

Who is the listed applicant for SCIg60 Infuser?

The FDA 510(k) record lists Emed Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCIg60 Infuser?

The FDA product code for SCIg60 Infuser is PKP.

列明Emed Technologies Corporation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。

K251105Tetra (TM-20)；Tetra (TM-50)K240148SCIg60 输液系统 K230883VersaPump 静脉注射系统 K213429AccuSert Needle Inserter K222087SCIg60 输液系统 K173783SCIg60 输液系统

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官方来源

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