FDA 510(k) Application Details - K180126

Device Classification Name	Monitor, Extracellular Fluid, Lymphedema, Extremity   More FDA Info for this Device
510(K) Number	K180126
Device Name	Monitor, Extracellular Fluid, Lymphedema, Extremity
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	870.2770   More FDA Info for this Regulation Number
Classification Product Code	OBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2018
Decision Date	04/16/2018
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