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FDA 510(k)

LiveOne

K-Number: K201302 · 2022-05-04

Decision Date2022-05-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LiveOne is the device name listed in this FDA 510(k) record. The listed applicant is Livemetric (Medical) S.A.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K201302. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LiveOne?

LiveOne is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is Livemetric (Medical) S.A.. The 510(k) number is K201302.

When did LiveOne receive FDA 510(k) clearance?

LiveOne received FDA 510(k) clearance on 2022-05-04, under 510(k) number K201302.

Who is the listed applicant for LiveOne?

The FDA 510(k) record lists Livemetric (Medical) S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiveOne?

The FDA product code for LiveOne is DXN.

Related Devices (Code: DXN)

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.

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.