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FDA 510(k)

truFreeze 系统

K号: K160273 · 2016-03-25

申请人Csa Medial, Inc.
决定日期2016-03-25
产品代码GEH
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

truFreeze System is the device name listed in this FDA 510(k) record. The listed applicant is Csa Medial, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K160273. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the truFreeze System?

truFreeze System is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Csa Medial, Inc.. The 510(k) number is K160273.

When did truFreeze System receive FDA 510(k) clearance?

truFreeze System received FDA 510(k) clearance on 2016-03-25, under 510(k) number K160273.

Who is the listed applicant for truFreeze System?

The FDA 510(k) record lists Csa Medial, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for truFreeze System?

The FDA product code for truFreeze System is GEH.

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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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相关器械（代码：GEH）

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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官方来源

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