MobileECG 2 BT
K号: K181658 · 2019-03-26
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决定日期2019-03-26
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
MobileECG 2 BT is the device name listed in this FDA 510(k) record. The listed applicant is Memtec Corporation. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K181658. 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 MobileECG 2 BT?
MobileECG 2 BT is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Memtec Corporation. The 510(k) number is K181658.
When did MobileECG 2 BT receive FDA 510(k) clearance?
MobileECG 2 BT received FDA 510(k) clearance on 2019-03-26, under 510(k) number K181658.
Who is the listed applicant for MobileECG 2 BT?
The FDA 510(k) record lists Memtec Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MobileECG 2 BT?
The FDA product code for MobileECG 2 BT 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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