FDA 510(k)

血壓振盪式監測器

K 號：K190927 · 2019-06-24

決定日期2019-06-24

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Oscillometric Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH. It received FDA 510(k) clearance on 2019-06-24 under 510(k) number K190927. 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 Oscillometric Blood Pressure Monitor?

Oscillometric Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-06-24. The listed applicant is Rudolf Riester GmbH. The 510(k) number is K190927.

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

Oscillometric Blood Pressure Monitor received FDA 510(k) clearance on 2019-06-24, under 510(k) number K190927.

Who is the listed applicant for Oscillometric Blood Pressure Monitor?

The FDA 510(k) record lists Rudolf Riester GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oscillometric Blood Pressure Monitor?

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

其他以 Rudolf Riester GmbH 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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官方來源

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