FDA 510(k)

ClariFix

K号: K190356 · 2019-02-26

决定日期2019-02-26

产品代码GEH

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决定实质等同

器械摘要

ClariFix is the device name listed in this FDA 510(k) record. The listed applicant is Arrinex, Inc.. It received FDA 510(k) clearance on 2019-02-26 under 510(k) number K190356. 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 ClariFix?

ClariFix is a medical device that received FDA 510(k) clearance on 2019-02-26. The listed applicant is Arrinex, Inc.. The 510(k) number is K190356.

When did ClariFix receive FDA 510(k) clearance?

ClariFix received FDA 510(k) clearance on 2019-02-26, under 510(k) number K190356.

Who is the listed applicant for ClariFix?

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

What is the FDA product code for ClariFix?

The FDA product code for ClariFix is GEH.

列明Arrinex, 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。

K162608ClariFix 设备 K160669ClariFix 设备

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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