FDA 510(k)

Medisono 超声诊断成像系统，型号 P1，P3 和 P10

K号: K163688 · 2017-02-23

决定日期2017-02-23

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is the device name listed in this FDA 510(k) record. The listed applicant is Medisono, LLC. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K163688. 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 Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Medisono, LLC. The 510(k) number is K163688.

When did Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 receive FDA 510(k) clearance?

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 received FDA 510(k) clearance on 2017-02-23, under 510(k) number K163688.

Who is the listed applicant for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

The FDA 510(k) record lists Medisono, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

The FDA product code for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is IYN.

列明Medisono, LLC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。

K170078Medisono 彩色多普勒超声系统，型号 P11 便携式，P11 EXPERT 便携式，P12 推车式，P12 Expert，P25 推车式，P25 Expert 推车式

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。