FDA 510(k)

Spectra Optia 血浆分离系统

K号: K153601 · 2016-01-14

决定日期2016-01-14

产品代码LKN

决定实质等同

器械摘要

Spectra Optia Apheresis System is the device name listed in this FDA 510(k) record. The listed applicant is Terumobct, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K153601. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

常见问题

What is the Spectra Optia Apheresis System?

Spectra Optia Apheresis System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Terumobct, Inc.. The 510(k) number is K153601.

When did Spectra Optia Apheresis System receive FDA 510(k) clearance?

Spectra Optia Apheresis System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K153601.

Who is the listed applicant for Spectra Optia Apheresis System?

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 Spectra Optia Apheresis System?

The FDA product code for Spectra Optia Apheresis System is LKN.

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。

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