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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 the device name listed in this FDA 510(k) record. The listed applicant is Mediana Co., Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) 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. The listed applicant is Mediana Co., Ltd.. The 510(k) number is K170497.

When did V10 receive FDA 510(k) clearance?

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

Who is the listed applicant for V10?

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

What is the FDA product code for V10?

The FDA product code for V10 is DXN.

Other records listing Mediana Co., 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.

K200434V20, V20a, AVSM3 SNFK160358DT-100K152659V10

Related Devices (Code: DXN)

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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