FDA 510(k)

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System

K号: K161359 · 2016-07-19

决定日期2016-07-19

产品代码IYN

咨询委员会RA

决定Substantially Equivalent

器械摘要

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System 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 2016-07-19 under 510(k) number K161359. 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,7400 Ultrasound System, 7410 Ultrasound System?

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-07-19. The listed applicant is Esaote, S.p.A.. The 510(k) number is K161359.

When did 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System receive FDA 510(k) clearance?

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System received FDA 510(k) clearance on 2016-07-19, under 510(k) number K161359.

Who is the listed applicant for 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System?

The FDA product code for 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System 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 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (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。