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510(k) Data Aggregation

    K Number
    K973735
    Device Name
    MICROVIT MT-100
    Manufacturer
    SCHILLER AMERICA, INC.
    Date Cleared
    1998-08-25

    (329 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHILLER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardiographs for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.
    Device Description
    The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardlographs for 24 hours, on two channels.
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    K Number
    K973751
    Device Name
    MT-200
    Manufacturer
    SCHILLER AMERICA, INC.
    Date Cleared
    1998-08-25

    (328 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHILLER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECG Holter evaluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter ECG recordings. The Holter recordings are used for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.
    Device Description
    The ECG Holter evoluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter EOG recordings. The Holter iscoralings are used for the diagnostics of symptomatic and asymptomatic arrhythings, i.e. bradyeardia, tachycardia, diagnastic of arthythinias in pattents with coraniary artery disease, in cardiomopathy, high blood pressure, long QT syndrome, A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of aliziniess or for controlling medical theraples, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic Ischemics. The software runs on Windows™ 95.
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    K Number
    K970879
    Device Name
    CARDIOVIT CS-200
    Manufacturer
    SCHILLER AMERICA, INC.
    Date Cleared
    1997-06-25

    (107 days)

    Product Code
    LOS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHILLER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.
    Device Description
    Not Found
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