FDA 510(k) Application Details - K190529

Device Classification Name	More FDA Info for this Device
510(K) Number	K190529
Device Name	SOZO
Applicant	ImpediMed Limited Unit 1, 50 Parker Court Pinkenba 4008 AU Other 510(k) Applications for this Company
Contact	Catherine Kingsford 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	03/04/2019
Decision Date	11/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review