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510(k) Data Aggregation

    K Number
    K013311
    Device Name
    MODIFICATION TO: POCKETVIEW ECG SOFTWARE
    Manufacturer
    MICROMEDICAL INDUSTRIES, LTD.
    Date Cleared
    2002-01-03

    (91 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROMEDICAL INDUSTRIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PocketView ECG software is a version of Cardioview™ 3000 software, a Windows-based program intended to interpret electrocardiograms. PocketView ECG software receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, and interpret the ECG signal. PocketView ECG Software allows the ECG information to be displayed on a commercially available personal digital assistant (PDA) running the Windows CE operating software.
    Device Description
    The proposed device is modification to the Cardioview™ 3000 software that allows the 12 Lead Simultaneous Cable to be linked to commercially available personal digital assistants (PDA) running the Windows CE operating system.
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    K Number
    K012540
    Device Name
    BLY-501 ADAPTOR
    Manufacturer
    MICROMEDICAL INDUSTRIES, LTD.
    Date Cleared
    2001-09-26

    (50 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROMEDICAL INDUSTRIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biolog™ 3000i Electrocardiograph with BLY-501 Adaptor detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical 12 Lead Simultaneous Cable. The Biolog™ 3000i Electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView 3000 software or to the Micromedical Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices. The device includes a Biolog™ 3000i Electrocardiograph, a User's Manual, a BLY-501 Adaptor, and accessories. It is intended for use with the Medtronic Physio Control LIFEPAK 500 defibrillator to visually display the patient's ECG to the user of the LIFEPAK 500 defibrillator.
    Device Description
    The proposed device is an ABS plastic docking station for the Biolog™ 3000i electrocardiograph that allows the Biolog™ 3000i electrocardiograph to be connected to a LIFEPAK 500 defibrillator. The defibrillator does not have a visual display, and the connection to the Biolog™ 3000 electrocardiograph allows the patient's EKG to be visually displayed on the Biolog™ 3000i electrocardiograph to enhance the usability of the defribrillator.
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    K Number
    K990266
    Device Name
    MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
    Manufacturer
    MICROMEDICAL INDUSTRIES, LTD.
    Date Cleared
    1999-02-02

    (5 days)

    Product Code
    LOS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROMEDICAL INDUSTRIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 12 Lead Simultaneous Cable is used to acquire a patient's ECG via 10 leads connected to a patient's chest. It converts the ECG signal into a digital format and transfers this information to a Micromedical monitor or software system using a proprietary digital data transfer protocol.
    Device Description
    The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical monitor or to a software system to display the ECG signal on a personal computer.
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