Device Classification Name monitor, extracellular fluid, lymphedema, extremity
510(k) Number K080825
Device Name IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
Applicant
IMPEDIMED PTY LTD.
UNIT 1, 50 PARKER COURT
pinkenba, qld,  AU 4008
Applicant Contact philip s auckland
Correspondent
IMPEDIMED PTY LTD.
UNIT 1, 50 PARKER COURT
pinkenba, qld,  AU 4008
Correspondent Contact philip s auckland
Regulation Number870.2770
Classification Product Code
OBH  
Date Received03/24/2008
Decision Date 10/03/2008
Decision substantially equivalent - kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No