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FDA 510(k)

ZEN-2090 Turbo

K-Number: K211780 · 2022-03-09

ApplicantGenoray Co., Ltd.
Decision Date2022-03-09
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZEN-2090 Turbo is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2022-03-09 under 510(k) number K211780. 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 ZEN-2090 Turbo?

ZEN-2090 Turbo is a medical device that received FDA 510(k) clearance on 2022-03-09. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K211780.

When did ZEN-2090 Turbo receive FDA 510(k) clearance?

ZEN-2090 Turbo received FDA 510(k) clearance on 2022-03-09, under 510(k) number K211780.

Who is the listed applicant for ZEN-2090 Turbo?

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

What is the FDA product code for ZEN-2090 Turbo?

The FDA product code for ZEN-2090 Turbo is OWB.

Other records listing Genoray Co., Ltd. as applicant

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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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