FDA 510(k)

多尼爾醫療設備 H Solvo 35 激光

K 號：K180350 · 2018-03-07

決定日期2018-03-07

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

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