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510(k) Data Aggregation

    K Number
    K971148
    Device Name
    700-SP SERIES DISPOSABLE STIMULATION ELECTRODES
    Manufacturer
    CARDIOTRONICS SYSTEMS, INC.
    Date Cleared
    1997-05-15

    (48 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTRONICS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970719
    Device Name
    700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES
    Manufacturer
    CARDIOTRONICS SYSTEMS, INC.
    Date Cleared
    1997-04-16

    (48 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTRONICS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 700-MP Series Radiolucent Multi-pad electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The MP designation refers to the multifunctionality of these electrodes wherein the separate ECG monitoring elements allow for continuous ECG monitoring through the attachment of separate ECG leadwires. The radiolucent substrate of these electrodes makes them particularly well suited for certain clinical applications involving radiographic viewing. The expected patient population for the use of these devices is primarily adults. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. Individual catalog numbers are labeled for more specific use based primarily on the interface connector and cable system which defines the host external device, such as an external defibrillator. The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labeled with one or more of the following intended uses: - External Defibrillation External Pacing ECG Monitorina Synchonized Cardioversion As with all electrodes of this type, labeling indicates that separate ECG electrodes are required for monitoring during external pacing. In the case of 700-MP Radiolucent Multi-Pad Electrodes these separate ECG monitoring electrodes are provided on the same foam backing for the optional attachment of separate ECG leadwires.
    Device Description
    The 700-MP Radiolucent Multi-Pad electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor. In addition, the 700-MP electrodes provide separate ECG monitoring elements on the same foam backing material for the attachment of standard ECG leadwires. Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is performed in accordance with established protocols. Optionally, the separate leadwires may be attached to the ECG monitoring elements provided on the foam back area. The 700-MP Radiolucent Multi-Pad electrodes are produced only in the Adult configuration. Leadwire sets having various lengths and interface connectors are added to the basic electrode style and may result in different catalog numbers to obtain combinations of end product design. The product line is further differentiated through trade name identification.
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    K Number
    K964991
    Device Name
    700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES
    Manufacturer
    CARDIOTRONICS SYSTEMS, INC.
    Date Cleared
    1997-01-15

    (33 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTRONICS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K964469
    Device Name
    700-F SERIES STIMULATION ELECTRODES
    Manufacturer
    CARDIOTRONICS SYSTEMS, INC.
    Date Cleared
    1996-12-11

    (34 days)

    Product Code
    LDD
    Regulation Number
    870.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTRONICS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 700-F series electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. The duration for use is to be less than 24 hours. Individual catalog numbers are labeled for more specific use based primarily on the Interface connector and cable system which defines the host external device, such as an external defibrillator. The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labels with one or more of the following intended uses: External Defibrillation External Pacing ECG Monitoring Synchonized Cardioversion
    Device Description
    The 700-F Series electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor. Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is new accordance with established protocols. The 700-F Series electrodes are produced in two basic styles; Adult and Child. Leadwire sets having various lengths and interface connectors are added to the basic electrode styles to obtain many combinations of end product design. The product line is further differentiated through trade name and OEM identification.
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