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510(k) Data Aggregation

    K Number
    K993878
    Device Name
    JE 2000
    Manufacturer
    Date Cleared
    2000-02-01

    (78 days)

    Product Code
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    JACK'S ELECTRODES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The electromyograph is intended to be used by a licensed practitioner, for the purpose of diagnostic neurological procedures.
    Device Description
    Not Found
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    K Number
    K974119
    Device Name
    DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
    Manufacturer
    Date Cleared
    1998-01-28

    (89 days)

    Product Code
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    JACK'S ELECTRODES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Acute Cardiac Ischemia Time-Insensitive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals . TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings. ACI-TIP! is intended for adult patient populations.
    Device Description
    Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is a software option for Marquette MAC-series electrocardiographs to aid the physician's decision-making process in a chest pain setting by using patient age, gender, chest pain status and ECG features to provide the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction).
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