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FDA 510(k)

SENYINT 远程咨询服务系统

K号: K162727 · 2018-02-08

决定日期2018-02-08
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

SENYINT Remote Consultation System is the device name listed in this FDA 510(k) record. The listed applicant is Dalian Senyint Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2018-02-08 under 510(k) number K162727. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SENYINT Remote Consultation System?

SENYINT Remote Consultation System is a medical device that received FDA 510(k) clearance on 2018-02-08. The listed applicant is Dalian Senyint Digital Medical System Co., Ltd.. The 510(k) number is K162727.

When did SENYINT Remote Consultation System receive FDA 510(k) clearance?

SENYINT Remote Consultation System received FDA 510(k) clearance on 2018-02-08, under 510(k) number K162727.

Who is the listed applicant for SENYINT Remote Consultation System?

The FDA 510(k) record lists Dalian Senyint Digital Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENYINT Remote Consultation System?

The FDA product code for SENYINT Remote Consultation System is LLZ.

相关临床试验

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相关器械(代码:LLZ)

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。

官方来源

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