FDA 510(k)

6400 超声系统（MyLabX6，MyLabX7）

K号: K190989 · 2019-05-10

决定日期2019-05-10

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

6400 Ultrasound System (MyLabX6, MyLabX7) 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 2019-05-10 under 510(k) number K190989. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 6400 Ultrasound System (MyLabX6, MyLabX7)?

6400 Ultrasound System (MyLabX6, MyLabX7) is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is Esaote, S.p.A.. The 510(k) number is K190989.

When did 6400 Ultrasound System (MyLabX6, MyLabX7) receive FDA 510(k) clearance?

6400 Ultrasound System (MyLabX6, MyLabX7) received FDA 510(k) clearance on 2019-05-10, under 510(k) number K190989.

Who is the listed applicant for 6400 Ultrasound System (MyLabX6, MyLabX7)?

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 6400 Ultrasound System (MyLabX6, MyLabX7)?

The FDA product code for 6400 Ultrasound System (MyLabX6, MyLabX7) is IYN.

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 →

相关器械（代码：IYN）

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。