FDA 510(k)

T-Cuff

K号: K162365 · 2017-02-16

决定日期2017-02-16

产品代码KCY

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决定实质等同

器械摘要

T-Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Terumobct, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162365. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the T-Cuff?

T-Cuff is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Terumobct, Inc.. The 510(k) number is K162365.

When did T-Cuff receive FDA 510(k) clearance?

T-Cuff received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162365.

Who is the listed applicant for T-Cuff?

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

What is the FDA product code for T-Cuff?

The FDA product code for T-Cuff is KCY.

列明Terumobct, 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。

K183081Spectra Optia 血浆分离系统 K181049Spectra Optia 血浆分离系统 K172590Spectra Optia 血浆分离系统 K153601Spectra Optia 血浆分离系统

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Terumobct, Inc.为申报人的其他记录

相关器械（代码：KCY）

官方来源