FDA 510(k)

Gemini 810+980 轟軟組織雷射

K 號：K192617 · 2020-02-20

決定日期2020-02-20

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

Gemini 810+980 Soft Tissue Laser is the device name listed in this FDA 510(k) record. The listed applicant is Azena Medical, LLC. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K192617. 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 Gemini 810+980 Soft Tissue Laser?

Gemini 810+980 Soft Tissue Laser is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is Azena Medical, LLC. The 510(k) number is K192617.

When did Gemini 810+980 Soft Tissue Laser receive FDA 510(k) clearance?

Gemini 810+980 Soft Tissue Laser received FDA 510(k) clearance on 2020-02-20, under 510(k) number K192617.

Who is the listed applicant for Gemini 810+980 Soft Tissue Laser?

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

What is the FDA product code for Gemini 810+980 Soft Tissue Laser?

The FDA product code for Gemini 810+980 Soft Tissue Laser is GEX. This falls under the Gastroenterology category.

其他以 Azena Medical, LLC 為申請人之記錄

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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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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官方來源

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