FDA 510(k)

Rapid Family

K号: K173169 · 2017-11-20

决定日期2017-11-20

产品代码GEX

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

Rapid Family is the device name listed in this FDA 510(k) record. The listed applicant is Sharplight Technologies, Ltd.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K173169. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Rapid Family?

Rapid Family is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Sharplight Technologies, Ltd.. The 510(k) number is K173169.

When did Rapid Family receive FDA 510(k) clearance?

Rapid Family received FDA 510(k) clearance on 2017-11-20, under 510(k) number K173169.

Who is the listed applicant for Rapid Family?

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

What is the FDA product code for Rapid Family?

The FDA product code for Rapid Family is GEX. This falls under the Gastroenterology category.

列明Sharplight Technologies, Ltd.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。

K233304Omnimax S3, Omnimax S4

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。