ASSURE 可穿戴心电图
K号: K233864 · 2024-05-07
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决定日期2024-05-07
产品代码MWJ
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
ASSURE Wearable ECG is the device name listed in this FDA 510(k) record. The listed applicant is Kestra Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K233864. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ASSURE Wearable ECG?
ASSURE Wearable ECG is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Kestra Medical Technologies, Inc.. The 510(k) number is K233864.
When did ASSURE Wearable ECG receive FDA 510(k) clearance?
ASSURE Wearable ECG received FDA 510(k) clearance on 2024-05-07, under 510(k) number K233864.
Who is the listed applicant for ASSURE Wearable ECG?
The FDA 510(k) record lists Kestra Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASSURE Wearable ECG?
The FDA product code for ASSURE Wearable ECG is MWJ.
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：MWJ）
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。
K254119可穿戴心电图记录仪（YMHeart XY-12）；可穿戴心电图记录仪（YMHeart XY-1201）；可穿戴心电图记录仪（YMHeart XY-1202）；可穿戴心电图记录仪（YMHeart XY-1203）；可穿戴心电图记录仪（YMHeart XY-03）；可穿戴心电图记录仪（YMHeart XY-0301）；可穿戴心电图记录仪（YMHeart XY-0302）；可穿戴心电图记录仪（YMHeart XY-0303）Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx（Cor MDx）Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE 心脏监测系统（mobiCARE-MC200M、mobiCARE-MC200ML、mobiCARE-MC200M7、mobiCARE-MC200ML7）Seers Technology Co., Ltd.K252839ZywieZ3 传感器 & 胶粘剂Zywie, Inc.K231424HeartBeam AIMIGo™系统Heartbeam, 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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