FDA 510(k)

MICRORUPTOR 6

K号: K160677 · 2017-05-19

决定日期2017-05-19

产品代码GEX

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决定实质等同

器械摘要

MICRORUPTOR 6 is the device name listed in this FDA 510(k) record. The listed applicant is Meridian AG. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K160677. 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 MICRORUPTOR 6?

MICRORUPTOR 6 is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Meridian AG. The 510(k) number is K160677.

When did MICRORUPTOR 6 receive FDA 510(k) clearance?

MICRORUPTOR 6 received FDA 510(k) clearance on 2017-05-19, under 510(k) number K160677.

Who is the listed applicant for MICRORUPTOR 6?

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

What is the FDA product code for MICRORUPTOR 6?

The FDA product code for MICRORUPTOR 6 is GEX. This falls under the Gastroenterology category.

列明Meridian AG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。

K232417MR Q；MR Q 仰卧；MR Q SLT K231011Merilas 532短脉冲，Merilas 577短脉冲，Merilas 810短脉冲

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