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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 K253224
Device Name MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
Applicant
ImpediMed Limited
Unit 1
50 Parker Court Pinkenba
Pinkenba,  AU 4008
Applicant Contact Richard Hines
Correspondent
ImpediMed Limited
Unit 1
50 Parker Court Pinkenba
Pinkenba,  AU 4008
Correspondent Contact Richard Hines
Regulation Number870.2770
Classification Product Code
OBH  
Subsequent Product Codes
DSB   MNW  
Date Received09/29/2025
Decision Date 01/28/2026
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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