FDA 510(k)

手臂自動血壓監測器

K 號：K151258 · 2016-02-18

申請人Shenzhen Pump Medical System Co., Ltd.

決定日期2016-02-18

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Arm automatic blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Pump Medical System Co., Ltd.. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K151258. 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 automatic blood pressure monitor?

Arm automatic blood pressure monitor is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Shenzhen Pump Medical System Co., Ltd.. The 510(k) number is K151258.

When did Arm automatic blood pressure monitor receive FDA 510(k) clearance?

Arm automatic blood pressure monitor received FDA 510(k) clearance on 2016-02-18, under 510(k) number K151258.

Who is the listed applicant for Arm automatic blood pressure monitor?

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

What is the FDA product code for Arm automatic blood pressure monitor?

The FDA product code for Arm automatic blood pressure monitor is DXN.

其他以 Shenzhen Pump Medical System 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。

K161712手臂自動血壓監測器 K161708手臂自動血壓監測器

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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官方來源

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