FDA 510(k)

EVO 平臺

K 號：K160368 · 2016-04-05

決定日期2016-04-05

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

EVO platform is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K160368. 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 EVO platform?

EVO platform is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Quanta System Spa. The 510(k) number is K160368.

When did EVO platform receive FDA 510(k) clearance?

EVO platform received FDA 510(k) clearance on 2016-04-05, under 510(k) number K160368.

Who is the listed applicant for EVO platform?

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

What is the FDA product code for EVO platform?

The FDA product code for EVO platform is GEX. This falls under the Gastroenterology category.

其他以 Quanta System Spa 為申請人之記錄

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