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FDA 510(k)

V20, V20a, AVSM3 SNF

K-Number: K200434 · 2020-10-09

ApplicantMediana Co., Ltd.
Decision Date2020-10-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

V20, V20a, AVSM3 SNF 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 2020-10-09 under 510(k) number K200434. 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 V20, V20a, AVSM3 SNF?

V20, V20a, AVSM3 SNF is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Mediana Co., Ltd.. The 510(k) number is K200434.

When did V20, V20a, AVSM3 SNF receive FDA 510(k) clearance?

V20, V20a, AVSM3 SNF received FDA 510(k) clearance on 2020-10-09, under 510(k) number K200434.

Who is the listed applicant for V20, V20a, AVSM3 SNF?

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 V20, V20a, AVSM3 SNF?

The FDA product code for V20, V20a, AVSM3 SNF 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.

K170497V10K160358DT-100K152659V10

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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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