FDA 510(k)

電子式血壓計

K 號：K222394 · 2023-03-03

申請人Qingdao Yasee Medical Device Co., Ltd.

決定日期2023-03-03

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Electronic Sphygmomanometers is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Yasee Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K222394. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Electronic Sphygmomanometers?

Electronic Sphygmomanometers is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Qingdao Yasee Medical Device Co., Ltd.. The 510(k) number is K222394.

When did Electronic Sphygmomanometers receive FDA 510(k) clearance?

Electronic Sphygmomanometers received FDA 510(k) clearance on 2023-03-03, under 510(k) number K222394.

Who is the listed applicant for Electronic Sphygmomanometers?

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

What is the FDA product code for Electronic Sphygmomanometers?

The FDA product code for Electronic Sphygmomanometers is DXN.

其他以 Qingdao Yasee Medical Device Co., Ltd. 為申請人之記錄

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K220084紅外線額頭體溫計

相關器械（代碼：DXN）

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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