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FDA 510(k)

手環式血壓監測器

K 號:K232815 · 2023-12-11

決定日期2023-12-11
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Wrist Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Yueja Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-11 under 510(k) number K232815. 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 Wrist Blood Pressure Monitor?

Wrist Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-12-11. The listed applicant is Zhuhai Yueja Medical Device Technology Co., Ltd.. The 510(k) number is K232815.

When did Wrist Blood Pressure Monitor receive FDA 510(k) clearance?

Wrist Blood Pressure Monitor received FDA 510(k) clearance on 2023-12-11, under 510(k) number K232815.

Who is the listed applicant for Wrist Blood Pressure Monitor?

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

What is the FDA product code for Wrist Blood Pressure Monitor?

The FDA product code for Wrist Blood Pressure Monitor is DXN.

相關臨床試驗

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其他以 Zhuhai Yueja Medical Device Technology Co., Ltd. 為申請人之記錄

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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。

官方來源

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