FDA 510(k)

JETT 電子血漿機型 II

K 號：K213247 · 2023-03-14

決定日期2023-03-14

產品代碼QVJ

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

JETT PLASMA Medical II is the device name listed in this FDA 510(k) record. The listed applicant is Compex, Spol, S.R.O.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K213247. The device is classified under product code QVJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JETT PLASMA Medical II?

JETT PLASMA Medical II is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Compex, Spol, S.R.O.. The 510(k) number is K213247.

When did JETT PLASMA Medical II receive FDA 510(k) clearance?

JETT PLASMA Medical II received FDA 510(k) clearance on 2023-03-14, under 510(k) number K213247.

Who is the listed applicant for JETT PLASMA Medical II?

The FDA 510(k) record lists Compex, Spol, S.R.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JETT PLASMA Medical II?

The FDA product code for JETT PLASMA Medical II is QVJ.

其他以 Compex, Spol, S.R.O. 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。

K240311JETT醫療II

相關器械（代碼：QVJ）

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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