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FDA 510(k)

HEPAFAT SCAN

K-Number: K122035 · 2013-12-13

ApplicantResonance Health Analysis Services Pty, Ltd.
Decision Date2013-12-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEPAFAT SCAN 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 2013-12-13 under 510(k) number K122035. 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 SCAN?

HEPAFAT SCAN is a medical device that received FDA 510(k) clearance on 2013-12-13. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K122035.

When did HEPAFAT SCAN receive FDA 510(k) clearance?

HEPAFAT SCAN received FDA 510(k) clearance on 2013-12-13, under 510(k) number K122035.

Who is the listed applicant for HEPAFAT SCAN?

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 HEPAFAT SCAN?

The FDA product code for HEPAFAT SCAN is LNH.

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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.

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