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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K193410
Device Name SOZO Body Fluid Analyzer
Applicant
ImpediMed Limited
Unit 1, 50 Parker Ct.
Pinkenba,  AU 4008
Applicant Contact Catherine Kingsford
Correspondent
Impedimed, Inc.
5900 Pasteur Ct., Unit 125
Carlsbad,  CA  92008
Correspondent Contact Reuben Lawson
Regulation Number870.2770
Classification Product Code
DSB  
Date Received12/09/2019
Decision Date 10/02/2020
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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