FDA 510(k) Applications for Medical Device Product Code "OBH"
(Monitor, Extracellular Fluid, Lymphedema, Extremity)

FDA 510(k) Number Applicant Device Name Decision Date
K220557 Delfin Technologies Ltd MoistureMeterD Compact, LymphScanner 05/27/2022
K143310 DELFIN TECHNOLOGIES LTD. MoisturemeterD 11/19/2015
K130338 IMPEDIMED LIMITED IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS 05/31/2013
K100811 IMPEDIMED LIMITED IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 11/04/2011
K172122 ImpediMed Limited SOZO 08/11/2017
K180126 ImpediMed Limited SOZO 04/16/2018
K230530 ImpediMed Limited SOZO Pro 05/04/2023
K080825 IMPEDIMED PTY LTD. IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 10/03/2008
K050415 IMPEDIMED PTY LTD. IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS 03/30/2007


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact