FDA 510(k)

上臂血壓監測器（XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09）

K 號：K241590 · 2025-02-03

申請人Guangdong Xinyu Electronic and Technology Co., Ltd.

決定日期2025-02-03

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Xinyu Electronic and Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-03 under 510(k) number K241590. 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 Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)?

Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) is a medical device that received FDA 510(k) clearance on 2025-02-03. The listed applicant is Guangdong Xinyu Electronic and Technology Co., Ltd.. The 510(k) number is K241590.

When did Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) receive FDA 510(k) clearance?

Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) received FDA 510(k) clearance on 2025-02-03, under 510(k) number K241590.

Who is the listed applicant for Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)?

The FDA 510(k) record lists Guangdong Xinyu Electronic and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)?

The FDA product code for Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) is DXN.

其他以 Guangdong Xinyu Electronic and Technology Co., Ltd. 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。

K241634手錶式血壓監測器（XY-W01A，XY-W01B）

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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