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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 K130338
Device Name IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
Applicant
ImpediMed Limited
555 13th St., NW
Washington,  DC  20004
Applicant Contact John j Smith, M.D., J.D.
Correspondent
ImpediMed Limited
555 13th St., NW
Washington,  DC  20004
Correspondent Contact John j Smith, M.D., J.D.
Regulation Number870.2770
Classification Product Code
OBH  
Date Received02/11/2013
Decision Date 05/31/2013
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
Predetermined Change
Control Plan Authorized		 No
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