FDA 510(k)

ArtPIX DRF

K 號：K202235 · 2020-09-03

決定日期2020-09-03

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

ArtPIX DRF is the device name listed in this FDA 510(k) record. The listed applicant is Cmt Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K202235. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ArtPIX DRF?

ArtPIX DRF is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Cmt Medical Technologies, Ltd.. The 510(k) number is K202235.

When did ArtPIX DRF receive FDA 510(k) clearance?

ArtPIX DRF received FDA 510(k) clearance on 2020-09-03, under 510(k) number K202235.

Who is the listed applicant for ArtPIX DRF?

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

What is the FDA product code for ArtPIX DRF?

The FDA product code for ArtPIX DRF is JAA.

其他以 Cmt Medical Technologies, Ltd. 為申請人之記錄

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K162224ArtPix 行動式 EZ2GO

相關器械（代碼：JAA）

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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