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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 K172122
Device Name SOZO
ImpediMed Limited
Unit 1
50 Parker Court
Pinkenba,  AU 4008
Applicant Contact Catherine Kingsford
ImpediMed Inc.
5900 Pasteur Court
Unit 125
Carlsbad,  CA  92008
Correspondent Contact Reuben Lawson
Regulation Number870.2770
Classification Product Code
Date Received07/13/2017
Decision Date 08/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No