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FDA 510(k)

Omega VL

K-Number: K162366 · 2018-03-02

ApplicantOv World Co., Ltd.
Decision Date2018-03-02
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Omega VL is a medical device manufactured by Ov World Co., Ltd.. It received FDA 510(k) clearance on 2018-03-02 under approval number K162366. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omega VL?

Omega VL is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Ov World Co., Ltd.. The 510(k) number is K162366.

When was Omega VL approved by the FDA?

Omega VL received FDA 510(k) clearance on 2018-03-02, under approval number K162366.

What company makes Omega VL?

Omega VL is manufactured by Ov World Co., Ltd..

What is the FDA product code for Omega VL?

The FDA product code for Omega VL is NEW.

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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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