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FDA 510(k)

Yxoss CBR®

K-Number: K192747 · 2020-06-17

ApplicantReoss GmbH
Decision Date2020-06-17
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Yxoss CBR® is the device name listed in this FDA 510(k) record. The listed applicant is Reoss GmbH. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K192747. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yxoss CBR®?

Yxoss CBR® is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Reoss GmbH. The 510(k) number is K192747.

When did Yxoss CBR® receive FDA 510(k) clearance?

Yxoss CBR® received FDA 510(k) clearance on 2020-06-17, under 510(k) number K192747.

Who is the listed applicant for Yxoss CBR®?

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

What is the FDA product code for Yxoss CBR®?

The FDA product code for Yxoss CBR® is JEY.

Related Devices (Code: JEY)

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

View on FDA Database →

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

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