FDA 510(k)

手環式血壓監測器

K 號：K162616 · 2018-03-09

申請人Xuzhou Yongkang Electronic Science Technology Co., Ltd.

決定日期2018-03-09

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Wrist Type 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 2018-03-09 under 510(k) number K162616. 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 Type Blood Pressure Monitor?

Wrist Type Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. The 510(k) number is K162616.

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

Wrist Type Blood Pressure Monitor received FDA 510(k) clearance on 2018-03-09, under 510(k) number K162616.

Who is the listed applicant for Wrist Type 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 Wrist Type Blood Pressure Monitor?

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

其他以 Xuzhou Yongkang Electronic Science 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。

K252709無線探頭型超音波掃描儀 K191571紫外線治療系統 K183491手臂血壓監測器 K180314紅外線體溫計 K161938指尖血氧計

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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