FDA 510(k)

FerriSmart Analysis System

K-Number: K182218 · 2018-11-30

ApplicantResonance Health Analysis Services Pty, Ltd.

Decision Date2018-11-30

Product CodePCS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FerriSmart Analysis System 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 2018-11-30 under 510(k) number K182218. 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 FerriSmart Analysis System?

FerriSmart Analysis System is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K182218.

When did FerriSmart Analysis System receive FDA 510(k) clearance?

FerriSmart Analysis System received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182218.

Who is the listed applicant for FerriSmart Analysis System?

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 FerriSmart Analysis System?

The FDA product code for FerriSmart Analysis System 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.

K231459HepaFatSmart (V2.0.0)K213776LiverSmart K201039HepaFat-AI

Related Devices (Code: PCS)

K213776LiverSmartResonance 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.