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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 K190529
Device Name SOZO
Applicant
ImpediMed Limited
Unit 1, 50 Parker Court
Pinkenba,  AU 4008
Applicant Contact Catherine Kingsford
Correspondent
ImpediMed, Inc.
5900 Pasteur Court, Unit 125
Carlsbad,  CA  92008
Correspondent Contact Reuben Lawson
Regulation Number870.2770
Classification Product Code
QJB  
Subsequent Product Codes
DSB   MNW  
Date Received03/04/2019
Decision Date 11/25/2019
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
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