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510(k) Data Aggregation

    K Number
    K110462
    Device Name
    KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE
    Manufacturer
    KEPLER MEDTEC
    Date Cleared
    2011-09-26

    (221 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    KEPLER MEDTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kepler MedTec Disposable Bipolar Cables are intended to connect an electrosurgical device to an electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.
    Device Description
    The Kepler MedTec Disposable Bipolar Cable includes available in multiple colors. The Kepler MedTec Disposable Bipolar Cable is provided sterile. Bipolar forceps (handpiece) are connected to a generator through a bipolar cable. The bipolar cable is flexible and delivers the electrical power from the generator to the binolar forcep. There is a male and female end termination on the cable. The male end termination (2-pin banana connector) is connected to the generator; the female end termination (2-pin plug type connector) to the bipolar forceps. The Kepler MedTec Disposable Bipolar Cable is compatible with: - Bipolar Forceps using standard US connection with 5.8 mm spaced pins . - . VallyLab, Conmed, Medtronic and Bovie generators
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    K Number
    K101660
    Device Name
    ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
    Manufacturer
    KEPLER MEDTEC
    Date Cleared
    2010-08-11

    (58 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    KEPLER MEDTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kepler MedTec Single Patient Use ECG Lead Wire is a electrode cable system used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. The Single Patient Use ECG Lead Wire Set is intended to be used by trained operators in a medical professional's environment.
    Device Description
    The Single Patient Use ECG Lead Wire is a single patient, electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
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