FDA 510(k)

Cydar EV

K号: K160088 · 2016-07-07

决定日期2016-07-07

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Cydar EV is the device name listed in this FDA 510(k) record. The listed applicant is Cydar , Ltd.. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K160088. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cydar EV?

Cydar EV is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Cydar , Ltd.. The 510(k) number is K160088.

When did Cydar EV receive FDA 510(k) clearance?

Cydar EV received FDA 510(k) clearance on 2016-07-07, under 510(k) number K160088.

Who is the listed applicant for Cydar EV?

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

What is the FDA product code for Cydar EV?

The FDA product code for Cydar EV is OWB.

列明Cydar , Ltd.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。

K212442Cydar EV（系列B）和Cydar EV Maps

官方来源

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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。