Search Results
Found 1 results
510(k) Data Aggregation
K Number
K143310Device Name
MoisturemeterD
Manufacturer
DELFIN TECHNOLOGIES LTD.
Date Cleared
2015-11-19
(366 days)
Product Code
OBH
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
DELFIN TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.
Device Description
The Delfin MoistureMeterD is a high-frequency bioelectrical analyzer used to detect tissue fluid. The device accurately measures voltage, current and the phase shift of the reflected current of the attenuated electric field and calculate capacitance and. moreover the tissue dielectric constant (TDC). The tissue dielectric constant (TDC) supports the measurement of local tissue fluid.
Ask a Question
Page 1 of 1