FDA 510(k)

YosemiteView 4343W/YosemiteView 3643W

K 號：K232058 · 2023-08-03

申請人Careray Digital Medical Technology Co., Ltd.

決定日期2023-08-03

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

YosemiteView 4343W/YosemiteView 3643W is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K232058. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the YosemiteView 4343W/YosemiteView 3643W?

YosemiteView 4343W/YosemiteView 3643W is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Careray Digital Medical Technology Co., Ltd.. The 510(k) number is K232058.

When did YosemiteView 4343W/YosemiteView 3643W receive FDA 510(k) clearance?

YosemiteView 4343W/YosemiteView 3643W received FDA 510(k) clearance on 2023-08-03, under 510(k) number K232058.

Who is the listed applicant for YosemiteView 4343W/YosemiteView 3643W?

The FDA 510(k) record lists Careray Digital Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YosemiteView 4343W/YosemiteView 3643W?

The FDA product code for YosemiteView 4343W/YosemiteView 3643W is MQB.

其他以 Careray Digital Medical Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：MQB）

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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