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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunct Monitor, Protein Calorie Malnutrition
510(k) Number K230531
Device Name SOZO Pro
Applicant
Impedimed Limited
Unit 1, 50 Parker Court
Pinkenba,  AU 4008
Applicant Contact Dennis Schlaht
Correspondent
Impedimed, Inc.
5900 Pasteur Court, Unit 125
Carlsbad,  CA  92008
Correspondent Contact Richard Hines
Regulation Number870.2770
Classification Product Code
QJB  
Subsequent Product Codes
DSB   MNW  
Date Received02/27/2023
Decision Date 05/04/2023
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
Predetermined Change
Control Plan Authorized		 No
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