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FDA 510(k)

腕3

K号: K160185 · 2016-03-01

决定日期2016-03-01
产品代码LNH
咨询委员会RA
决定实质等同

器械摘要

Wrist 3 is the device name listed in this FDA 510(k) record. The listed applicant is Aspect Imaging, Ltd.. It received FDA 510(k) clearance on 2016-03-01 under 510(k) number K160185. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wrist 3?

Wrist 3 is a medical device that received FDA 510(k) clearance on 2016-03-01. The listed applicant is Aspect Imaging, Ltd.. The 510(k) number is K160185.

When did Wrist 3 receive FDA 510(k) clearance?

Wrist 3 received FDA 510(k) clearance on 2016-03-01, under 510(k) number K160185.

Who is the listed applicant for Wrist 3?

FDA 510(k)记录将 Aspect Imaging, Ltd. 列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Wrist 3?

The FDA product code for Wrist 3 is LNH.

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。

列明Aspect Imaging, Ltd.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。

相关器械(代码:LNH)

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

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。

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