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510(k) Data Aggregation
K Number
K963578Device Name
PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)
Manufacturer
Date Cleared
1997-06-30
(297 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
INTL. PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PC-ECG system is a fully featured, non-invasive, real-time, 12-lead ECG system capable of recording, display and storage of data using a PC (personal computer). It is used in doctor's offices by cardiologists to record the clectrical heart signals (electrocardingram) of patients in order to detect abnormal heart conditions.
Patients are hooked up to the PC-FCG system via cables connected to the extremities and the chest using rubberized disks which contain in a small central depression a paste.
The device is for prescription use only.
Device Description
Versatile 12-lead electrocardiograph system (ECG) for use with PCs.
Recording and display of 1, 3, 6, 12 channels
Monitoring of up to 12 channels with acoustic, analogue and digital pulse signal
Single user system or network ready
Storage of unlimited number of 10 sec. ECGs
High quality print of 6, 12 leads with variable speed
Patient database
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