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510(k) Data Aggregation
K Number
K052295Device Name
CARDIOSOFT PC ECG, USB VERSION
Manufacturer
Date Cleared
2006-01-13
(143 days)
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
CARDIOSOFT, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CardioSoft PC ECG is intended for use in acquiring, processing, recording, archiving and displaying electrocardiographic information. It can provide serial comparison of ECG information to facilitate review of current and previous records and is intended for use by trained operators. The system offers no diagnostic opinion to the user, but may be used by a physician to render his or her own medical opinion.
Device Description
The CardioSoft PC ECG is an electrocardiograph that detects signals associated with cardiac activity and produces an ECG graphical record. The device operates on a personal computer through a USB hardware module. The device can acquire, process, record, archive and display 3-, 6-, or 12-lead ECG and vector cardiograms. The device provides portable ECG with important advantages compared to traditional machines.
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