HepaFatSmart (V2.0.0)
K-Number: K231459 · 2023-06-20
Decision Date2023-06-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HepaFatSmart (V2.0.0) is a medical device manufactured by Resonance Health Analysis Services Pty, Ltd.. It received FDA 510(k) clearance on 2023-06-20 under approval number K231459. 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 HepaFatSmart (V2.0.0)?
HepaFatSmart (V2.0.0) is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K231459.
When was HepaFatSmart (V2.0.0) approved by the FDA?
HepaFatSmart (V2.0.0) received FDA 510(k) clearance on 2023-06-20, under approval number K231459.
What company makes HepaFatSmart (V2.0.0)?
HepaFatSmart (V2.0.0) is manufactured by Resonance Health Analysis Services Pty, Ltd..
What is the FDA product code for HepaFatSmart (V2.0.0)?
The FDA product code for HepaFatSmart (V2.0.0) is LNH.
Other Devices by Resonance Health Analysis Services Pty, Ltd.
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Official Source
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