FDA 510(k) Application Details - K230531

Device Classification Name	More FDA Info for this Device
510(K) Number	K230531
Device Name	SOZO Pro
Applicant	ImpediMed Limited Unit 1, 50 Parker Court Pinkenba 4008 AU Other 510(k) Applications for this Company
Contact	Dennis Schlaht Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2023
Decision Date	05/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review