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FDA 510(k)

Cydar EV (Series B) and Cydar EV Maps

K-Number: K212442 · 2021-12-03

ApplicantCydar , Ltd.
Decision Date2021-12-03
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

K160088Cydar EV

Related Devices (Code: OWB)

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.

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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.

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