FDA 510(k)

Viola

K-Number: K190264 · 2019-08-15

Decision Date2019-08-15

Product CodeNEW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Viola is the device name listed in this FDA 510(k) record. The listed applicant is Meditime Co., Ltd.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) 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. The listed applicant is Meditime Co., Ltd.. The 510(k) number is K190264.

When did Viola receive FDA 510(k) clearance?

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

Who is the listed applicant for Viola?

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

What is the FDA product code for Viola?

The FDA product code for Viola is NEW.

Related Devices (Code: NEW)

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.