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510(k) Data Aggregation
K Number
K170928Device Name
CADence System
Manufacturer
Date Cleared
2017-08-03
(127 days)
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
AUM Cardiovascular, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CADence System is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensors used to record electrical activity of the heart (ECG), a single-use Patient Booklet, and the CADence Software application.
CADence Software is a clinical decision support tool intended to aid a qualified clinician's analysis of normal/ physiological and pathological heart murmurs after simultaneous recording of cardiac sounds and ECG.
The device must be used in a clinical setting by trained personnel. The automated analysis of cardiac sounds by the CADence System are only significant when used in conjunction with physician oversight as well as consideration of all other relevant patient information. All relevant patient information must be taken into consideration before making a diagnosis. The CADence System is not intended to be a stand-alone diagnostic device. It does not supersede the judgment of the clinician.
Device Description
The CADence System is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensors used to record electrical activity of the heart (ECG), a single-use Patient Booklet, and the CADence Software application.
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