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510(k) Data Aggregation
K Number
K990809Device Name
CADISCOPE ELECTRONIC STETHOSCOPE
Manufacturer
CADITEC AG
Date Cleared
1999-06-09
(90 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
CADITEC AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in an Einthoven Triangle.
It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient.
It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds. When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying the existence of cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.
Device Description
The CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in a standard Einthoven Triangle.
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