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FDA 510(k)

BPro BT 便携式血压监测系统及 BProSoft BT PC 软件

K号: K173028 · 2018-06-21

申请人Healthstats International Pte. , Ltd.
决定日期2018-06-21
产品代码DXN
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is the device name listed in this FDA 510(k) record. The listed applicant is Healthstats International Pte. , Ltd.. It received FDA 510(k) clearance on 2018-06-21 under 510(k) number K173028. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is a medical device that received FDA 510(k) clearance on 2018-06-21. The listed applicant is Healthstats International Pte. , Ltd.. The 510(k) number is K173028.

When did BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software receive FDA 510(k) clearance?

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software received FDA 510(k) clearance on 2018-06-21, under 510(k) number K173028.

Who is the listed applicant for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

The FDA 510(k) record lists Healthstats International Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

The FDA product code for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is DXN.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：DXN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261929上臂血压计（BP7155D）OMRON Healthcare, Inc.K254000快乐健康血压计Happy Health, Inc.K262658自动数字血压计（LD-526）Honsun (Nantong) Co., Ltd.K261394臂式全自动数字血压计（DBP-6186 Plus，DBP-6286B Plus，DBP-61E3 Plus，DBP-61E2 Plus，DBP-62E3B Plus，DBP-62E2B Plus）JOYTECH Healthcare Co., Ltd.K253425臂式全自动数字血压计（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.

官方来源

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