LiverSmart

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Resonance Health Analysis Services Pty Ltd

The following data is part of a premarket notification filed by Resonance Health Analysis Services Pty Ltd with the FDA for Liversmart.

Pre-market Notification Details

Device IDK213776
510k NumberK213776
Device Name:LiverSmart
ClassificationLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Applicant Resonance Health Analysis Services Pty Ltd 141 Burswood Road Perth,  AU 6100
ContactMitchell Wells
CorrespondentMitchell Wells
Resonance Health Analysis Services Pty Ltd 141 Burswood Road Perth,  AU 6100
Product CodePCS  
CFR Regulation Number892.1001 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-02
Decision Date2021-12-29

Trademark Results [LiverSmart]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIVERSMART
LIVERSMART
86509717 4803520 Live/Registered
NATURENETICS, INC.
2015-01-21
LIVERSMART
LIVERSMART
79328449 not registered Live/Pending
Resonance Health Analysis Services Pty Ltd
2021-10-13

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