FDA 510(k)

LiverSmart

K-Number: K213776 · 2021-12-29

ApplicantResonance Health Analysis Services Pty, Ltd.

Decision Date2021-12-29

Product CodePCS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LiverSmart is the device name listed in this FDA 510(k) record. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. It received FDA 510(k) clearance on 2021-12-29 under 510(k) number K213776. The device is classified under product code PCS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LiverSmart?

LiverSmart is a medical device that received FDA 510(k) clearance on 2021-12-29. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K213776.

When did LiverSmart receive FDA 510(k) clearance?

LiverSmart received FDA 510(k) clearance on 2021-12-29, under 510(k) number K213776.

Who is the listed applicant for LiverSmart?

The FDA 510(k) record lists Resonance Health Analysis Services Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiverSmart?

The FDA product code for LiverSmart is PCS.

Other records listing Resonance Health Analysis Services Pty, Ltd. as applicant

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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Related Devices (Code: PCS)

K182218FerriSmart Analysis SystemResonance Health Analysis Services Pty, Ltd.

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.