FDA 510(k)

Embrace

K号: K181861 · 2018-12-20

决定日期2018-12-20

产品代码POS

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决定实质等同

器械摘要

Embrace is the device name listed in this FDA 510(k) record. The listed applicant is Empatica S.r.l.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K181861. The device is classified under product code POS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Embrace?

Embrace is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Empatica S.r.l.. The 510(k) number is K181861.

When did Embrace receive FDA 510(k) clearance?

Embrace received FDA 510(k) clearance on 2018-12-20, under 510(k) number K181861.

Who is the listed applicant for Embrace?

FDA 510(k)记录中列出Empatica S.r.l.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Embrace?

The FDA product code for Embrace is POS.

列明Empatica S.r.l.为申报人的其他记录

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。

K260374帕金森病监测用Empatica健康监测平台；EmbracePlus；EmbraceMini；Empatica护理；Empatica的PKG监测器；护理门户 K252981EmbraceMini K250515EpiMonitor K242737Empatica 健康监测平台; EmbracePlus; Empatica Care; Care Portal K232915EpiMonitor K230457Empatica 健康监测平台; EmbracePlus; Empatica Care; Care Portal

查看所有 9 个设备 →

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。