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FDA 510(k)

V10

K-Number: K170497 · 2017-12-15

ApplicantMediana Co., Ltd.
Decision Date2017-12-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

V10 is a medical device manufactured by Mediana Co., Ltd.. It received FDA 510(k) clearance on 2017-12-15 under approval number K170497. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V10?

V10 is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by Mediana Co., Ltd.. The 510(k) number is K170497.

When was V10 approved by the FDA?

V10 received FDA 510(k) clearance on 2017-12-15, under approval number K170497.

What company makes V10?

V10 is manufactured by Mediana Co., Ltd..

What is the FDA product code for V10?

The FDA product code for V10 is DXN.

Other Devices by Mediana Co., Ltd.

K152659V10 K160358DT-100 K200434V20, V20a, AVSM3 SNF

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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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