BodyGuardian 远程监控系统
K号: K192732 · 2020-03-26
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决定日期2020-03-26
产品代码DSI
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]
---
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
BodyGuardian Remote Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Preventice Technologies, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K192732. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BodyGuardian Remote Monitoring System?
BodyGuardian Remote Monitoring System is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Preventice Technologies, Inc.. The 510(k) number is K192732.
When did BodyGuardian Remote Monitoring System receive FDA 510(k) clearance?
BodyGuardian Remote Monitoring System received FDA 510(k) clearance on 2020-03-26, under 510(k) number K192732.
Who is the listed applicant for BodyGuardian Remote Monitoring System?
The FDA 510(k) record lists Preventice Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BodyGuardian Remote Monitoring System?
The FDA product code for BodyGuardian Remote Monitoring System is DSI.
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：DSI）
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。
K243349BodyGuardian 远程监控系统（BGRMS v3.0）Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® 无线便携式心电图监测和检测系统 (32000)Infobionic, Inc.K240177Zio AT®设备（A100A1001）iRhythm Technologies, Inc.K230265MoMe® ARC 无线便携式心电图监测和检测系统Infobionic, Inc.K231276SmartCardia 7L 平台Smartcardia SAK193104统一心律失常诊断系统 智能ECG IVMedicalgorithmics S.A.
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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