免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Evolv 模型 BP7000 上臂血壓監測器

K 號:K162092 · 2016-11-22

決定日期2016-11-22
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Evolv Model BP7000 Upper Arm Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K162092. 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 Evolv Model BP7000 Upper Arm Blood Pressure Monitor?

Evolv Model BP7000 Upper Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K162092.

When did Evolv Model BP7000 Upper Arm Blood Pressure Monitor receive FDA 510(k) clearance?

Evolv Model BP7000 Upper Arm Blood Pressure Monitor received FDA 510(k) clearance on 2016-11-22, under 510(k) number K162092.

Who is the listed applicant for Evolv Model BP7000 Upper Arm Blood Pressure Monitor?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evolv Model BP7000 Upper Arm Blood Pressure Monitor?

The FDA product code for Evolv Model BP7000 Upper Arm Blood Pressure Monitor is DXN.

相關臨床試驗

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。

其他以 Omron Healthcare, Inc. 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。

查看所有 15 項裝置 →

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑