FDA 510(k)

Cydar EV（系列B）和Cydar EV Maps

K号: K212442 · 2021-12-03

决定日期2021-12-03

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Cydar EV (Series B) and Cydar EV Maps is the device name listed in this FDA 510(k) record. The listed applicant is Cydar , Ltd.. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K212442. 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 (Series B) and Cydar EV Maps?

Cydar EV (Series B) and Cydar EV Maps is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Cydar , Ltd.. The 510(k) number is K212442.

When did Cydar EV (Series B) and Cydar EV Maps receive FDA 510(k) clearance?

Cydar EV (Series B) and Cydar EV Maps received FDA 510(k) clearance on 2021-12-03, under 510(k) number K212442.

Who is the listed applicant for Cydar EV (Series B) and Cydar EV Maps?

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 (Series B) and Cydar EV Maps?

The FDA product code for Cydar EV (Series B) and Cydar EV Maps is OWB.

列明Cydar , Ltd.为申报人的其他记录

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K160088Cydar EV

官方来源

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