FDA 510(k)

Ellipse 补充工具托盘

K号: K151594 · 2016-01-25

决定日期2016-01-25

产品代码KCT

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

Ellipse Supplemental Instrument Trays is the device name listed in this FDA 510(k) record. The listed applicant is Ellipse Technologies, Incorporated. It received FDA 510(k) clearance on 2016-01-25 under 510(k) number K151594. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ellipse Supplemental Instrument Trays?

Ellipse Supplemental Instrument Trays is a medical device that received FDA 510(k) clearance on 2016-01-25. The listed applicant is Ellipse Technologies, Incorporated. The 510(k) number is K151594.

When did Ellipse Supplemental Instrument Trays receive FDA 510(k) clearance?

Ellipse Supplemental Instrument Trays received FDA 510(k) clearance on 2016-01-25, under 510(k) number K151594.

Who is the listed applicant for Ellipse Supplemental Instrument Trays?

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

What is the FDA product code for Ellipse Supplemental Instrument Trays?

The FDA product code for Ellipse Supplemental Instrument Trays is KCT.

列明Ellipse Technologies, Incorporated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。

K160267PRECICE创伤钉系统

官方来源

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