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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 K050415
Device Name IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS
Applicant
IMPEDIMED PTY LTD.
BUILDING 4B/2404 LOGAN ROAD
EIGHT MILE PLAINS
brisbane, queensland,  AU 4113
Applicant Contact neville bertwistle
Correspondent
IMPEDIMED PTY LTD.
BUILDING 4B/2404 LOGAN ROAD
EIGHT MILE PLAINS
brisbane, queensland,  AU 4113
Correspondent Contact neville bertwistle
Regulation Number870.2770
Classification Product Code
OBH  
Date Received02/18/2005
Decision Date 03/30/2007
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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