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FDA 510(k)

SUITESTENSA

K号: K163668 · 2017-06-23

申请人Ebit Srl
决定日期2017-06-23
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

SUITESTENSA is the device name listed in this FDA 510(k) record. The listed applicant is Ebit Srl. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K163668. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SUITESTENSA?

SUITESTENSA is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Ebit Srl. The 510(k) number is K163668.

When did SUITESTENSA receive FDA 510(k) clearance?

SUITESTENSA received FDA 510(k) clearance on 2017-06-23, under 510(k) number K163668.

Who is the listed applicant for SUITESTENSA?

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

What is the FDA product code for SUITESTENSA?

The FDA product code for SUITESTENSA is LLZ.

相关临床试验

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相关器械(代码:LLZ)

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。

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