FDA 510(k)

Cydar EV

K-Number: K160088 · 2016-07-07

Decision Date2016-07-07

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Cydar , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212442Cydar EV (Series B) and Cydar EV Maps

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.