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510(k) Data Aggregation
K Number
K160656Device Name
CorSens
Manufacturer
CorSens Medical Ltd.
Date Cleared
2016-11-21
(258 days)
Product Code
DXR
Regulation Number
870.2320Why did this record match?
Applicant Name (Manufacturer) :
CorSens Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CorSens Device records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. CorSens Device may be used as a tool to measure the timing of part of the cardiac cycle for adult population.
Device Description
CorSens Device senses and analyzes the mechanical movement of the heart. This is accomplished by 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motions.
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