SmartCardia 7L 平台
K号: K231276 · 2023-08-30
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决定日期2023-08-30
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
SmartCardia 7L Platform is the device name listed in this FDA 510(k) record. The listed applicant is Smartcardia SA. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K231276. 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 SmartCardia 7L Platform?
SmartCardia 7L Platform is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Smartcardia SA. The 510(k) number is K231276.
When did SmartCardia 7L Platform receive FDA 510(k) clearance?
SmartCardia 7L Platform received FDA 510(k) clearance on 2023-08-30, under 510(k) number K231276.
Who is the listed applicant for SmartCardia 7L Platform?
The FDA 510(k) record lists Smartcardia SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartCardia 7L Platform?
The FDA product code for SmartCardia 7L Platform 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。
列明Smartcardia SA为申报人的其他记录
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.K193104统一心律失常诊断系统 智能ECG IVMedicalgorithmics S.A.K192732BodyGuardian 远程监控系统Preventice Technologies, 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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