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510(k) Data Aggregation

    K Number
    K992584
    Device Name
    PE 501 PC-ECG MONITOR
    Manufacturer
    Date Cleared
    2000-01-13

    (164 days)

    Product Code
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    NHE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PE 501 PC-ECG is indicated for acquiring and displaying 2 channel ECG signals through a personal computer and transferring the recorded ECG signals to a remote computer. It is designed for stationary use and is not for ambulatory use. It is intended for use primarily in out-patient clinics. The PE 501 PC-ECG device should be operated by a licensed healthcare practitioner.
    Device Description
    The PE 501 PC-ECG Monitor is a battery-powered, personal computer based electrocardiograph monitoring device. It is designed to acquire, display and record 2 channel ECG signals. The ECG signals are sent to the computer through a serial port and displayed on the computer screen. The ECG signals associated with personal information can be stored into the computer hard disk or floppy disk. Desired segments of the recorded ECG signals can be printed on any Windows compatible printers. The recorded ECG signals can be easily retrieved and can also be transferred to a remote computer with floppy disk, direct machine to machine or E-mail.
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