Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Kowa Co. Ltd. Chofu. It received FDA 510(k) clearance on 2019-02-12 under approval 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. It is manufactured by Kowa Co. Ltd. Chofu. The 510(k) number is K190056.

When was KOWA VK-2s approved by the FDA?

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

What company makes KOWA VK-2s?

KOWA VK-2s is manufactured by Kowa Co. Ltd. Chofu.

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

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

Related Devices (Code: NFJ)

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.