FDA 510(k)

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun

K号: K192951 · 2020-03-26

决定日期2020-03-26

产品代码GEX

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决定实质等同

器械摘要

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun is the device name listed in this FDA 510(k) record. The listed applicant is Ellipse A/S. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K192951. 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 Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun?

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Ellipse A/S. The 510(k) number is K192951.

When did Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun receive FDA 510(k) clearance?

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun received FDA 510(k) clearance on 2020-03-26, under 510(k) number K192951.

Who is the listed applicant for Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun?

The FDA 510(k) record lists Ellipse A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun?

The FDA product code for Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun is GEX. This falls under the Gastroenterology category.

列明Ellipse A/S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。

K180406Ellipse Ydun K161162Frax 1550用于Ellipse Nordlys/ Ellipse Nordlys+，Ellipse Sirius，Ellipse Infinity，Ellipse Mjolner，Ellipse Nordlys Ultra

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