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510(k) Data Aggregation

    K Number
    K012404
    Device Name
    K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
    Manufacturer
    KATECHO, INC.
    Date Cleared
    2001-10-12

    (74 days)

    Product Code
    DRO
    Regulation Number
    870.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    KATECHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.
    Device Description
    Katecho KDP-85 Adult Defib/Pace Multifunction Electrode. The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin.
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    K Number
    K010543
    Device Name
    KM-30 TENS ELECTRODE
    Manufacturer
    KATECHO, INC.
    Date Cleared
    2001-05-23

    (89 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    KATECHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003228
    Device Name
    K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
    Manufacturer
    KATECHO, INC.
    Date Cleared
    2000-12-14

    (59 days)

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

    KATECHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002806
    Device Name
    K-DEFIB/PACE, MODEL KDP-60A
    Manufacturer
    KATECHO, INC.
    Date Cleared
    2000-11-21

    (74 days)

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

    KATECHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000870
    Device Name
    KM-10 TENS ELECTRODE
    Manufacturer
    KATECHO, INC.
    Date Cleared
    2000-11-07

    (232 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    KATECHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993745
    Device Name
    K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
    Manufacturer
    KATECHO, INC.
    Date Cleared
    2000-02-03

    (90 days)

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

    KATECHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Katecho External Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-80 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) card1ac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum). The Katecho KDP-80 Defilb/Pace Electrodes are designed for, and to be used interchangeably with Physio Control Defibrillation Devices that use Quik Combo Electrodes.
    Device Description
    KATECHO KDP-80 Defib/Pace Electrodes
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    K Number
    K991007
    Device Name
    K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
    Manufacturer
    KATECHO, INC.
    Date Cleared
    1999-08-23

    (150 days)

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

    KATECHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Katecho External Radiolucent electrode is indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KRT-60 Radiolucent electrode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum). This device has been tested to the ANSI/AAMI DF2-1996 standard for use with equipment: Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.
    Device Description
    K-Defib/Pace Radio Lucent Adult Electrode Model KRT-60
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    K Number
    K981737
    Device Name
    K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
    Manufacturer
    KATECHO, INC.
    Date Cleared
    1998-12-09

    (205 days)

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

    KATECHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Katecho "K-Defib/Pace Adult Electrode it is indicated for use in external Pacing. Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KDP-60 K-Defib/Pace Adult Electode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation or external pacing these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joulc maximum). This device has been tested to the ANSI/AAMI DIF39-1993 standard for use with equipment by the following manufacturers; Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.
    Device Description
    Not Found
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