FDA 510(k) Application Details - K230530

Device Classification Name	Monitor, Extracellular Fluid, Lymphedema, Extremity   More FDA Info for this Device
510(K) Number	K230530
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	Dennis Schlaht 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	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