MoistureMeterD Compact, LymphScanner

Monitor, Extracellular Fluid, Lymphedema, Extremity

Delfin Technologies Ltd

The following data is part of a premarket notification filed by Delfin Technologies Ltd with the FDA for Moisturemeterd Compact, Lymphscanner.

Pre-market Notification Details

Device IDK220557
510k NumberK220557
Device Name:MoistureMeterD Compact, LymphScanner
ClassificationMonitor, Extracellular Fluid, Lymphedema, Extremity
Applicant Delfin Technologies Ltd Microkatu 1 Kuopio,  FI 70210
ContactJouni Nuutinen
CorrespondentPatrick Danciu
F Care Systems USA (dba: Delfin USA LLC) 11098 Biscayne Blvd, Suite 301 Miami,  FL  33161
Product CodeOBH  
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-05-27

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