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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 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
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