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FDA 510(k)

數位自動手腕式血壓監測器 SWBPM22 系列

K 號：K163113 · 2017-01-19

申請人Grandway Technology (Shenzhen) Limited
決定日期2017-01-19
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K163113. 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 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series?

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K163113.

When did Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series receive FDA 510(k) clearance?

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series received FDA 510(k) clearance on 2017-01-19, under 510(k) number K163113.

Who is the listed applicant for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series?

The FDA 510(k) record lists Grandway Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series?

The FDA product code for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series 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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Grandway Technology (Shenzhen) Limited 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。

K191593數位自動血壓監測儀 MD36 系列K171379數位自動手腕式血壓監測器 MD4300K163648數位自動血壓監測器 BPM41 系列數位自動血壓監測器 BPM45 系列K163679數位自動血壓監測儀 MD3600

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

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