FDA 510(k)

RHIN1 笔

K号: K192471 · 2019-12-20

决定日期2019-12-20

产品代码GEI

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决定实质等同

器械摘要

RHIN1 Stylus is the device name listed in this FDA 510(k) record. The listed applicant is Aerin Medical, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192471. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RHIN1 Stylus?

RHIN1 Stylus is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K192471.

When did RHIN1 Stylus receive FDA 510(k) clearance?

RHIN1 Stylus received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192471.

Who is the listed applicant for RHIN1 Stylus?

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

What is the FDA product code for RHIN1 Stylus?

The FDA product code for RHIN1 Stylus is GEI.

列明Aerin 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。

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相关器械（代码：GEI）

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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