FDA 510(k)

AROMA GRAND

K 號：K211637 · 2021-09-03

決定日期2021-09-03

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

AROMA GRAND is the device name listed in this FDA 510(k) record. The listed applicant is Daeju Meditech Engineering Co., Ltd.. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K211637. 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 AROMA GRAND?

AROMA GRAND is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Daeju Meditech Engineering Co., Ltd.. The 510(k) number is K211637.

When did AROMA GRAND receive FDA 510(k) clearance?

AROMA GRAND received FDA 510(k) clearance on 2021-09-03, under 510(k) number K211637.

Who is the listed applicant for AROMA GRAND?

The FDA 510(k) record lists Daeju Meditech Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AROMA GRAND?

The FDA product code for AROMA GRAND is GEX. This falls under the Gastroenterology category.

其他以 Daeju Meditech Engineering Co., Ltd. 為申請人之記錄

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