FDA 510(k)

四重雷射系統，型號：CPMT ARES、CPMT NEMESIS、CPMT NYX PLUS、CPMT GRACE PLUS

K 號：K222915 · 2022-11-15

申請人Canadian Pioneer Medical Technology Corporation (Cpmt Laser)

決定日期2022-11-15

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

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Pioneer Medical Technology Corporation (Cpmt Laser). It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K222915. 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 Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS?

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Canadian Pioneer Medical Technology Corporation (Cpmt Laser). The 510(k) number is K222915.

When did Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS receive FDA 510(k) clearance?

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS received FDA 510(k) clearance on 2022-11-15, under 510(k) number K222915.

Who is the listed applicant for Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS?

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

What is the FDA product code for Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS?

The FDA product code for Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS is GEX. This falls under the Gastroenterology category.

其他以 Canadian Pioneer Medical Technology Corporation (Cpmt Laser) 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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官方來源

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