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FDA 510(k)

數位血壓監測器（手臂型）

K 號：K231245 · 2023-11-22

申請人Guangdong Genial Technology Co., Ltd.
決定日期2023-11-22
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Digital Blood Pressure Monitor (Arm Type) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K231245. 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 Blood Pressure Monitor (Arm Type)?

Digital Blood Pressure Monitor (Arm Type) is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Guangdong Genial Technology Co., Ltd.. The 510(k) number is K231245.

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

Digital Blood Pressure Monitor (Arm Type) received FDA 510(k) clearance on 2023-11-22, under 510(k) number K231245.

Who is the listed applicant for Digital Blood Pressure Monitor (Arm Type)?

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

What is the FDA product code for Digital Blood Pressure Monitor (Arm Type)?

The FDA product code for Digital Blood Pressure Monitor (Arm Type) 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 Guangdong Genial 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。

K240333穿戴式數字鹽水燒 (T31)K232678數位體溫計，型號 T28，T28LK231250數位血壓監測器K231243手指針式血氧濃度計

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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