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510(k) K220557

Device
MoistureMeterD Compact, LymphScanner
Applicant
Delfin Technologies Ltd
510(k) number
K220557
Product code
OBH  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-27
Date received
2022-02-28
Regulation
870.2770
Classification name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Medical specialty
Cardiovascular
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jouni Nuutinen
Address
Microkatu 1 Kuopio FI 70210 70210

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OBH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited2026-01-28
K230530SOZO ProImpediMed Limited2023-05-04
K180126SOZOImpediMed Limited2018-04-16
K172122SOZOImpediMed Limited2017-08-11
K143310MoisturemeterDDelfin Technologies, Ltd.2015-11-19
K130338IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSISImpediMed Limited2013-05-31
K100811IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400ImpediMed Limited2011-11-04
K080825IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400Impedimed Pty , Ltd.2008-10-03
K050415IMPEDIMED-EXTRACELLULAR FLUID ANALYSISImpedimed Pty , Ltd.2007-03-30

Legacy Summary#

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FDA Review#

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