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510(k) Data Aggregation

    K Number
    K010955
    Device Name
    BMT ANSCORE HEALTH MANAGEMENT SYSTEM
    Manufacturer
    BOSTON MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-04-26

    (27 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993875
    Device Name
    BMT ANSCORE HEALTH MANAGEMENT SYSTEM
    Manufacturer
    BOSTON MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2000-08-11

    (270 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anscore™ system is intended for use in heart rate variability (HRV) measurements in response to paced respiration and controlled exercises.
    Device Description
    The Anscore™ is a cart-based system with a computer-based user interface and data acquisition system for testing, data collection and data transmission for remote processing. The device features a 3 lead ECG and a breathing apparatus, in order to conduct heart rate variability testing. Heart rate variability testing is one of various measurement tools used by physicians in their assessment of autonomic function and dysfunction.
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    K Number
    K991831
    Device Name
    BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
    Manufacturer
    BOSTON MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-06-11

    (14 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications: The ANScore™ System is intended for use in heart rate variability measurements in response to paced respiration and controlled exercises. It is not intended for any specific clinical diagnosis. Assessment is indicated for patients in the physician office or hospital environment
    Device Description
    The ANScore™ System is a cart-based system with a computer-based user interface and data acquisition system for testing, data collection and data transmission for remote processing. The device features a 3 lead ECG, an optional blood pressure monitor, and a breathing apparatus.
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