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510(k) Data Aggregation

    K Number
    K023414
    Device Name
    MIDA ALGORITHM REV. B
    Manufacturer
    ORTIVUS AB
    Date Cleared
    2003-12-05

    (420 days)

    Product Code
    DYC, 74D
    Regulation Number
    870.2400
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    Product Code :

    DYC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use only by a digital device to measure ST-segment shifts. Assessment of real time ST segment analysis in adult patients. The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 lbs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) The use of EASI leads implies that the results may not be of diagnostic quality.
    Device Description
    The new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI.
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