FDA 510(k)

Terason uSmart 3200T Plus超声系统

K号: K201633 · 2020-07-02

决定日期2020-07-02

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Terason uSmart 3200T Plus Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corporation. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K201633. 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 Terason uSmart 3200T Plus Ultrasound System?

Terason uSmart 3200T Plus Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Teratech Corporation. The 510(k) number is K201633.

When did Terason uSmart 3200T Plus Ultrasound System receive FDA 510(k) clearance?

Terason uSmart 3200T Plus Ultrasound System received FDA 510(k) clearance on 2020-07-02, under 510(k) number K201633.

Who is the listed applicant for Terason uSmart 3200T Plus Ultrasound System?

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

What is the FDA product code for Terason uSmart 3200T Plus Ultrasound System?

The FDA product code for Terason uSmart 3200T Plus Ultrasound System is IYN.

列明Teratech Corporation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。

K193510Terason uSmart3200T超声系统

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

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