LiverSmart— 510(k) K213776

Name: FDA 510(k) clearance K213776
Creator: U.S. Food and Drug Administration
Published: 2021-12-29

Substantially Equivalent

Resonance Health Analysis Services Pty, Ltd.

FDA 510(k) clearance K213776 for LiverSmart, Substantially Equivalent on 2021-12-29. Applicant: Resonance Health Analysis Services Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Resonance Health Analysis Services Pty, Ltd.
Product code: Code PCS
Device class: Class 2
Regulation: 21 CFR 892.1001
Advisory panel: Radiology
Date received: 2021-12-02
Decision date: 2021-12-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Perth, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.