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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Extracellular Fluid, Lymphedema, Extremity
510(k) Number K100811
Device Name IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
Applicant
IMPEDIMED LIMITED
5959 CORNERSTONE COURT
WEST SUITE 100
SAN DIEGO,  CA  92121
Applicant Contact ALDEN KAY
Correspondent
IMPEDIMED LIMITED
5959 CORNERSTONE COURT
WEST SUITE 100
SAN DIEGO,  CA  92121
Correspondent Contact ALDEN KAY
Regulation Number870.2770
Classification Product Code
OBH  
Date Received03/22/2010
Decision Date 11/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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