Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061977
    Device Name
    PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
    Manufacturer
    Date Cleared
    2006-07-21

    (8 days)

    Product Code
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINMED, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - 1-12 lead electrocardiograph capable of recording and transmitting standard ECGs for . the purpose of cardiac monitoring and diagnosis; the system incorporates recording/ transmitting circuitry, a package of firmware and software, and is intended for use by a medical professional - . The ECG can be recorded and transmitted to a local or remote receiving station for consultation with a medical professional - The ECG can be recorded and transmitted to a local or remote hand-held device or a . Personal Computer or a printer for viewing and processing - . Allows patients at remote locations to display and transmit their ECG data to medical professionals via a communication device to a remote server - . Intended for self-testing by patients and by healtheare professionals at home and in medical settings
    Device Description
    Pelex-04 wireless electrocardiograph with software accessories (Personal Heart Expert software, Pelex Server&Database software, and Pelex Explorer software)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1