FDA 510(k)

Joule diVa 系統

K 號：K213761 · 2022-07-19

決定日期2022-07-19

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

Joule diVa System is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2022-07-19 under 510(k) number K213761. 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 Joule diVa System?

Joule diVa System is a medical device that received FDA 510(k) clearance on 2022-07-19. The listed applicant is Sciton, Inc. The 510(k) number is K213761.

When did Joule diVa System receive FDA 510(k) clearance?

Joule diVa System received FDA 510(k) clearance on 2022-07-19, under 510(k) number K213761.

Who is the listed applicant for Joule diVa System?

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

What is the FDA product code for Joule diVa System?

The FDA product code for Joule diVa System is GEX. This falls under the Gastroenterology category.

其他以 Sciton, Inc 為申請人之記錄

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