FDA 510(k)

全自动(NIBP)血壓監測器-HL158TB

K 號：K190134 · 2019-05-20

決定日期2019-05-20

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2019-05-20 under 510(k) number K190134. 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 Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is a medical device that received FDA 510(k) clearance on 2019-05-20. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K190134.

When did Full Automatic (NIBP) Blood Pressure Monitor-HL158TB receive FDA 510(k) clearance?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB received FDA 510(k) clearance on 2019-05-20, under 510(k) number K190134.

Who is the listed applicant for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

The FDA 510(k) record lists Health & Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is DXN.

其他以 Health & Life 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。

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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。

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