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FDA 510(k)

可穿戴设备；底座；小号带、中号带、大号带；多设备充电器；医院启动包

K号: K182543 · 2018-11-14

申请人Snap40, Ltd.
决定日期2018-11-14
产品代码MSX
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

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is the device name listed in this FDA 510(k) record. The listed applicant is Snap40, Ltd.. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K182543. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Snap40, Ltd.. The 510(k) number is K182543.

When did Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package receive FDA 510(k) clearance?

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package received FDA 510(k) clearance on 2018-11-14, under 510(k) number K182543.

Who is the listed applicant for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

The FDA 510(k) record lists Snap40, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

The FDA product code for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is MSX.

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：MSX）

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。

K261287迪吉斯塔特护理Ascom Ums Srl UnipersonaleK260211仪表盘（P007000）Hill-Rom, Inc.K261367Corsano CardioWatch 287-2系统Corsano Health B.V.K253654IntelliVue 测量架 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270虎联警报管理TigerconnectK242728BeneVision 中央监护系统Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方来源

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