HepaFat-AI
K-Number: K201039 · 2020-12-07
Decision Date2020-12-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HepaFat-AI is a medical device manufactured by Resonance Health Analysis Services Pty, Ltd.. It received FDA 510(k) clearance on 2020-12-07 under approval number K201039. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HepaFat-AI?
HepaFat-AI is a medical device that received FDA 510(k) clearance on 2020-12-07. It is manufactured by Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K201039.
When was HepaFat-AI approved by the FDA?
HepaFat-AI received FDA 510(k) clearance on 2020-12-07, under approval number K201039.
What company makes HepaFat-AI?
HepaFat-AI is manufactured by Resonance Health Analysis Services Pty, Ltd..
What is the FDA product code for HepaFat-AI?
The FDA product code for HepaFat-AI is LNH.
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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.