FDA 510(k)

KOWA VK-2s

K-Number: K190056 · 2019-02-12

Decision Date2019-02-12

Product CodeNFJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

KOWA VK-2s is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Co. Ltd. Chofu. It received FDA 510(k) clearance on 2019-02-12 under 510(k) number K190056. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA VK-2s?

KOWA VK-2s is a medical device that received FDA 510(k) clearance on 2019-02-12. The listed applicant is Kowa Co. Ltd. Chofu. The 510(k) number is K190056.

When did KOWA VK-2s receive FDA 510(k) clearance?

KOWA VK-2s received FDA 510(k) clearance on 2019-02-12, under 510(k) number K190056.

Who is the listed applicant for KOWA VK-2s?

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

What is the FDA product code for KOWA VK-2s?

The FDA product code for KOWA VK-2s is NFJ.

Related Devices (Code: NFJ)

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.