FDA 510(k)

Joimax Intracs 系统

K号: K192663 · 2020-07-30

决定日期2020-07-30

产品代码OLO

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决定实质等同

器械摘要

Joimax Intracs System is the device name listed in this FDA 510(k) record. The listed applicant is Joimax GmbH. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K192663. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Joimax Intracs System?

Joimax Intracs System is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Joimax GmbH. The 510(k) number is K192663.

When did Joimax Intracs System receive FDA 510(k) clearance?

Joimax Intracs System received FDA 510(k) clearance on 2020-07-30, under 510(k) number K192663.

Who is the listed applicant for Joimax Intracs System?

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

What is the FDA product code for Joimax Intracs System?

The FDA product code for Joimax Intracs System is OLO.

列明Joimax GmbH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。

K203014EndoLIF Delta-Cage 和 DoubleWedge-Cage K192680Percusys® Plus椎弓根螺钉系统 K170358joimax 内蒸发器 2 K161378joimax 电外科器械

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