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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 K220557
Device Name MoistureMeterD Compact, LymphScanner
Delfin Technologies Ltd
Microkatu 1
Kuopio,  FI 70210
Applicant Contact Jouni Nuutinen
F Care Systems USA (dba: Delfin USA LLC)
11098 Biscayne Blvd, Suite 301
Miami,  FL  33161
Correspondent Contact Patrick Danciu
Regulation Number870.2770
Classification Product Code
Date Received02/28/2022
Decision Date 05/27/2022
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