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FDA 510(k)

ZywieZ3 传感器 & 胶粘剂

K号: K252839 · 2026-06-18

申请人Zywie, Inc.
决定日期2026-06-18
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

ZywieZ3 Sensor & Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Zywie, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K252839. 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 ZywieZ3 Sensor & Adhesive?

ZywieZ3 Sensor & Adhesive is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Zywie, Inc.. The 510(k) number is K252839.

When did ZywieZ3 Sensor & Adhesive receive FDA 510(k) clearance?

ZywieZ3 Sensor & Adhesive received FDA 510(k) clearance on 2026-06-18, under 510(k) number K252839.

Who is the listed applicant for ZywieZ3 Sensor & Adhesive?

The FDA 510(k) record lists Zywie, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZywieZ3 Sensor & Adhesive?

The FDA product code for ZywieZ3 Sensor & Adhesive 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 AGK253384mobiCARE 心脏监测系统（mobiCARE-MC200M、mobiCARE-MC200ML、mobiCARE-MC200M7、mobiCARE-MC200ML7）Seers Technology Co., Ltd.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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