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FDA 510(k)

mobiCARE 心脏监测系统（mobiCARE-MC200M、mobiCARE-MC200ML、mobiCARE-MC200M7、mobiCARE-MC200ML7）

K号: K253384 · 2026-06-25

申请人Seers Technology Co., Ltd.
决定日期2026-06-25
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： --- 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

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) is the device name listed in this FDA 510(k) record. The listed applicant is Seers Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253384. 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 mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Seers Technology Co., Ltd.. The 510(k) number is K253384.

When did mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) receive FDA 510(k) clearance?

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253384.

Who is the listed applicant for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

The FDA 510(k) record lists Seers Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

The FDA product code for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 AGK252839ZywieZ3 传感器 & 胶粘剂Zywie, Inc.K231424HeartBeam AIMIGo™系统Heartbeam, Inc.K233864ASSURE 可穿戴心电图Kestra Medical Technologies, Inc.

官方来源

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