FDA 510(k)

雷射治療系統，型號：Hera，Armo

K 號：K212793 · 2021-10-25

申請人Canadian Pioneer Medical Technology Corporation

決定日期2021-10-25

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

Laser Treatment System, Model: Hera, Armo is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Pioneer Medical Technology Corporation. It received FDA 510(k) clearance on 2021-10-25 under 510(k) number K212793. 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 Laser Treatment System, Model: Hera, Armo?

Laser Treatment System, Model: Hera, Armo is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Canadian Pioneer Medical Technology Corporation. The 510(k) number is K212793.

When did Laser Treatment System, Model: Hera, Armo receive FDA 510(k) clearance?

Laser Treatment System, Model: Hera, Armo received FDA 510(k) clearance on 2021-10-25, under 510(k) number K212793.

Who is the listed applicant for Laser Treatment System, Model: Hera, Armo?

The FDA 510(k) record lists Canadian Pioneer Medical Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser Treatment System, Model: Hera, Armo?

The FDA product code for Laser Treatment System, Model: Hera, Armo is GEX. This falls under the Gastroenterology category.

其他以 Canadian Pioneer Medical Technology Corporation 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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相關器械（代碼：GEX）

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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