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FDA 510(k)

Zeroveno

K-Number: K192337 · 2020-06-22

ApplicantDimedi Co., Ltd.
Decision Date2020-06-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zeroveno is a medical device manufactured by Dimedi Co., Ltd.. It received FDA 510(k) clearance on 2020-06-22 under approval number K192337. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeroveno?

Zeroveno is a medical device that received FDA 510(k) clearance on 2020-06-22. It is manufactured by Dimedi Co., Ltd.. The 510(k) number is K192337.

When was Zeroveno approved by the FDA?

Zeroveno received FDA 510(k) clearance on 2020-06-22, under approval number K192337.

What company makes Zeroveno?

Zeroveno is manufactured by Dimedi Co., Ltd..

What is the FDA product code for Zeroveno?

The FDA product code for Zeroveno is JOW.

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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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