G0血压监测系统（G0）
K号: K250415 · 2025-07-02
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申请人Aktiia SA
决定日期2025-07-02
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：
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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]
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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
G0 Blood Pressure Monitoring System (G0) is the device name listed in this FDA 510(k) record. The listed applicant is Aktiia SA. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250415. 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 G0 Blood Pressure Monitoring System (G0)?
G0 Blood Pressure Monitoring System (G0) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Aktiia SA. The 510(k) number is K250415.
When did G0 Blood Pressure Monitoring System (G0) receive FDA 510(k) clearance?
G0 Blood Pressure Monitoring System (G0) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250415.
Who is the listed applicant for G0 Blood Pressure Monitoring System (G0)?
The FDA 510(k) record lists Aktiia SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for G0 Blood Pressure Monitoring System (G0)?
The FDA product code for G0 Blood Pressure Monitoring System (G0) 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。
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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