FDA 510(k)

TAP 血液采集装置

K号: K161521 · 2017-02-16

决定日期2017-02-16

产品代码PRJ

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决定实质等同

器械摘要

TAP Blood Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Seventh Sense Biosystems, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K161521. The device is classified under product code PRJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TAP Blood Collection Device?

TAP Blood Collection Device is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Seventh Sense Biosystems, Inc.. The 510(k) number is K161521.

When did TAP Blood Collection Device receive FDA 510(k) clearance?

TAP Blood Collection Device received FDA 510(k) clearance on 2017-02-16, under 510(k) number K161521.

Who is the listed applicant for TAP Blood Collection Device?

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

What is the FDA product code for TAP Blood Collection Device?

The FDA product code for TAP Blood Collection Device is PRJ.

列明Seventh Sense Biosystems, 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。

K190225TAP 血液采集装置

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