FDA 510(k)

Alma Q

K 號：K170850 · 2017-06-15

決定日期2017-06-15

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

Alma Q is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers , Ltd.. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K170850. 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 Alma Q?

Alma Q is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Alma Lasers , Ltd.. The 510(k) number is K170850.

When did Alma Q receive FDA 510(k) clearance?

Alma Q received FDA 510(k) clearance on 2017-06-15, under 510(k) number K170850.

Who is the listed applicant for Alma Q?

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

What is the FDA product code for Alma Q?

The FDA product code for Alma Q is GEX. This falls under the Gastroenterology category.

其他以 Alma Lasers , Ltd. 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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