FDA 510(k)

血壓監測器

K 號：K162089 · 2017-02-10

申請人Beijing Choice Electronic Technology Co., Ltd.

決定日期2017-02-10

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K162089. 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 Blood Pressure Monitor?

Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K162089.

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

Blood Pressure Monitor received FDA 510(k) clearance on 2017-02-10, under 510(k) number K162089.

Who is the listed applicant for Blood Pressure Monitor?

The FDA 510(k) record lists Beijing Choice Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Pressure Monitor?

The FDA product code for Blood Pressure Monitor is DXN.

其他以 Beijing Choice Electronic 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。

K232975心脈血氧濃度計（MD300C228）K230587手環式血氧濃度計 K230172心電血氧濃度計 K220101心電血氧濃度計 K221992電子脈衝刺激器 K211400心電血氧濃度計

查看所有 14 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。

K261929上臂血壓監測器（BP7155D）OMRON Healthcare, Inc.K254000快樂健康血壓監測器Happy Health, Inc.K262658自動數位血壓監測器（LD-526）Honsun (Nantong) Co., Ltd.K261394臂式全自動數字血壓計（DBP-6186 Plus、DBP-6286B Plus、DBP-61E3 Plus、DBP-61E2 Plus、DBP-62E3B Plus、DBP-62E2B Plus）JOYTECH Healthcare Co., Ltd.K253425臂式全自动數字血壓監測儀（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

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。