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)

血壓監測器（BBZ32-AA01）

K 號：K240832 · 2024-06-07

申請人Guangdong Transtek Medical Electronics Co., Ltd.
決定日期2024-06-07
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Blood Pressure Monitor (BBZ32-AA01) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K240832. 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 (BBZ32-AA01)?

Blood Pressure Monitor (BBZ32-AA01) is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K240832.

When did Blood Pressure Monitor (BBZ32-AA01) receive FDA 510(k) clearance?

Blood Pressure Monitor (BBZ32-AA01) received FDA 510(k) clearance on 2024-06-07, under 510(k) number K240832.

Who is the listed applicant for Blood Pressure Monitor (BBZ32-AA01)?

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

What is the FDA product code for Blood Pressure Monitor (BBZ32-AA01)?

The FDA product code for Blood Pressure Monitor (BBZ32-AA01) 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 Transtek Medical Electronics 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。

K243060TeleRPM Gen2 血糖監測系統K241351血壓監測器（TMB-2092-G）K240254血壓監測器（TMB-2296-BT）K240102血壓監測器（TMB-2287-B）K233130血壓監測器K232713血壓監測器

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。

↑