FDA 510(k)

G-scan Brio，S-scan

K号: K161973 · 2016-10-25

决定日期2016-10-25

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

G-scan Brio, S-scan is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K161973. 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 G-scan Brio, S-scan?

G-scan Brio, S-scan is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Esaote, S.p.A.. The 510(k) number is K161973.

When did G-scan Brio, S-scan receive FDA 510(k) clearance?

G-scan Brio, S-scan received FDA 510(k) clearance on 2016-10-25, under 510(k) number K161973.

Who is the listed applicant for G-scan Brio, S-scan?

FDA 510(k)记录中列出Esaote, S.p.A.为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for G-scan Brio, S-scan?

The FDA product code for G-scan Brio, S-scan is LNH.

列明Esaote, S.p.A.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。

K261331I-Genius（100019400）K2532886450 超声系统 (MyLabE80)；6450 超声系统 (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 超声系统 (MyLabC25)；7600 超声系统 (MyLabC30)K2432536600 超声系统 (MyLabA50)；6600 超声系统 (MyLabA70)

查看所有 25 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。

器械摘要

常见问题

列明Esaote, S.p.A.为申报人的其他记录

相关器械（代码：LNH）

官方来源