FDA 510(k)

Indego(R)

K号: K173530 · 2018-01-31

决定日期2018-01-31

产品代码PHL

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Indego(R) is the device name listed in this FDA 510(k) record. The listed applicant is Parker-Hannifin Corporation. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K173530. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Indego(R)?

Indego(R) is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is Parker-Hannifin Corporation. The 510(k) number is K173530.

When did Indego(R) receive FDA 510(k) clearance?

Indego(R) received FDA 510(k) clearance on 2018-01-31, under 510(k) number K173530.

Who is the listed applicant for Indego(R)?

The FDA 510(k) record lists Parker-Hannifin Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Indego(R)?

The FDA product code for Indego(R) is PHL.

列明Parker-Hannifin Corporation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。

K241465Midas 流量计；eAVS K223452Nitronox Scavenger Plus K171334Indego K152416Indego

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。