FDA 510(k)

UST-5550-R；UST-5536-R；L43K

K号: K152126 · 2016-08-17

决定日期2016-08-17

产品代码ITX

咨询委员会RA

决定实质等同

器械摘要

UST-5550-R; UST-5536-R; L43K is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Aloka Medical America, Inc.. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K152126. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UST-5550-R; UST-5536-R; L43K?

UST-5550-R; UST-5536-R; L43K is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Hitachi Aloka Medical America, Inc.. The 510(k) number is K152126.

When did UST-5550-R; UST-5536-R; L43K receive FDA 510(k) clearance?

UST-5550-R; UST-5536-R; L43K received FDA 510(k) clearance on 2016-08-17, under 510(k) number K152126.

Who is the listed applicant for UST-5550-R; UST-5536-R; L43K?

The FDA 510(k) record lists Hitachi Aloka Medical America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UST-5550-R; UST-5536-R; L43K?

The FDA product code for UST-5550-R; UST-5536-R; L43K is ITX.

列明Hitachi Aloka Medical America, Inc.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。

K153421HI VISION ASCENDUS，HV ASCENDUS，ASCENDUS

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Hitachi Aloka Medical America, Inc.为申报人的其他记录

相关器械（代码：ITX）

官方来源