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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
Applicant
Delfin Technologies, Ltd.
Microkatu 1
Kuopio,  FI 70210
Applicant Contact Jouni Nuutinen
Correspondent
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
OBH  
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
Predetermined Change
Control Plan Authorized		 No
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