FDA 510(k)

Dornier Medilas H Solvo 35 激光

K号: K180350 · 2018-03-07

决定日期2018-03-07

产品代码GEX

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决定实质等同

器械摘要

Dornier Medilas H Solvo 35 Laser is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America. It received FDA 510(k) clearance on 2018-03-07 under 510(k) number K180350. 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 Dornier Medilas H Solvo 35 Laser?

Dornier Medilas H Solvo 35 Laser is a medical device that received FDA 510(k) clearance on 2018-03-07. The listed applicant is Dornier Medtech America. The 510(k) number is K180350.

When did Dornier Medilas H Solvo 35 Laser receive FDA 510(k) clearance?

Dornier Medilas H Solvo 35 Laser received FDA 510(k) clearance on 2018-03-07, under 510(k) number K180350.

Who is the listed applicant for Dornier Medilas H Solvo 35 Laser?

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

What is the FDA product code for Dornier Medilas H Solvo 35 Laser?

The FDA product code for Dornier Medilas H Solvo 35 Laser is GEX. This falls under the Gastroenterology category.

列明Dornier Medtech America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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