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FDA 510(k)

Viola

K-Number: K190264 · 2019-08-15

ApplicantMeditime Co., Ltd.
Decision Date2019-08-15
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Viola is a medical device manufactured by Meditime Co., Ltd.. It received FDA 510(k) clearance on 2019-08-15 under approval number K190264. 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 Viola?

Viola is a medical device that received FDA 510(k) clearance on 2019-08-15. It is manufactured by Meditime Co., Ltd.. The 510(k) number is K190264.

When was Viola approved by the FDA?

Viola received FDA 510(k) clearance on 2019-08-15, under approval number K190264.

What company makes Viola?

Viola is manufactured by Meditime Co., Ltd..

What is the FDA product code for Viola?

The FDA product code for Viola 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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