FDA 510(k) Application Details - K182218

Device Classification Name	More FDA Info for this Device
510(K) Number	K182218
Device Name	FerriSmart Analysis System
Applicant	Resonance Health Analysis Services Pty Ltd 141 Burswood Road Burswood 6100 AU Other 510(k) Applications for this Company
Contact	Celine Royet 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	08/15/2018
Decision Date	11/30/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review