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FDA 510(k)

手臂血壓監測器

K 號：K183491 · 2019-03-24

申請人Xuzhou Yongkang Electronic Science Technology Co., Ltd.
決定日期2019-03-24
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 is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-03-24 under 510(k) number K183491. 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?

Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-03-24. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. The 510(k) number is K183491.

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

Arm Blood Pressure Monitor received FDA 510(k) clearance on 2019-03-24, under 510(k) number K183491.

Who is the listed applicant for Arm Blood Pressure Monitor?

The FDA 510(k) record lists Xuzhou Yongkang Electronic Science 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?

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

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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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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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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