FDA 510(k)

truFreeze 系统

K号: K163244 · 2017-05-24

决定日期2017-05-24

产品代码GEH

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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 Medical, Inc.. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K163244. 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 2017-05-24. The listed applicant is CSA Medical, Inc.. The 510(k) number is K163244.

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

truFreeze System received FDA 510(k) clearance on 2017-05-24, under 510(k) number K163244.

Who is the listed applicant for truFreeze System?

The FDA 510(k) record lists CSA Medical, 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.

列明CSA Medical, Inc.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。

K201183涡流径向喷射导管 K171626truFreeze 系统 K172041truFreeze 系统 K171522truFreeze 快速AV喷雾套装 K162695truFreeze 系统 K161557truFreeze 系统

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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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