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510(k) Data Aggregation

    K Number
    K080232
    Device Name
    ZOLL E SERIES 12SL, ANALYSIS OPTION
    Manufacturer
    ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
    Date Cleared
    2008-04-23

    (84 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K042007
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZOLL E Series with 12SL™ is intended for the recording and automated analysis of 12-Lead ECG signals acquired from adult and pediatric patients in the supine, resting position.

    The 12SL™ Analysis Option using the GE/Marquette 12SLTM Algorithm is useful in the diagnosis of patients with acute myocardial infarction (AMI) and is useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. The 12-Lead ECG Analysis is indicated for the recording and analysis of 12 Lead ECG signals acquired from adult and pediatric patients in the supine, resting position. The Acute Cardiac Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI) and Thrombolytic Predictive Instrument (TPI) are decision aids for qualified clinicians who may currently wish to calculate ACI-TIPI and TPI in adult patients.

    12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction.

    Device Description

    The ZOLL E Series products (K042007) combine a defibrillator, ECG Monitor, Noninvasive Transcutaneous Pacing, Pulse Oximetry, End Tidal CO2 , 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement Invasive Blood Pressure and Temperature and data printing and recording in a single instrument.

    The ZOLL E Series 12SLTM Analysis Option utilizes the same interpretive features and functions to those of the currently marketed ZOLL E Series 12SL™ Analysis Option (K042007). The device acquires an ECG signal through a 10wire cable assembly and commonly used patient electrodes placed in a standard 12-Lead configuration. The device is also capable of storing that data to memory and/or transmitting that data via cellular telephone, RS232 port, or wirelessly using Bluetooth™ technology.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or the study that proves the device meets the acceptance criteria. It primarily focuses on the device's description, intended use, substantial equivalence claim, and general performance and safety testing. There are no details on specific performance metrics, sample sizes for test or training sets, ground truth establishment, or any comparative effectiveness studies.

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