FDA 510(k) Application Details - K213776

Device Classification Name	More FDA Info for this Device
510(K) Number	K213776
Device Name	LiverSmart
Applicant	Resonance Health Analysis Services Pty Ltd 141 Burswood Road Perth 6100 AU Other 510(k) Applications for this Company
Contact	Mitchell Wells Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2021
Decision Date	12/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review