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    K Number
    K083735
    Device Name
    ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
    Manufacturer
    MEDTECHS, LLC
    Date Cleared
    2009-02-18

    (64 days)

    Product Code
    JOM, DPS
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTECHS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANSHA (QHRV1) is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rase by electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
    Device Description
    ANSHA -QHRV1 has the same intended use as the legally marketed predicate device systems. The ANSHA -QHRV1 is intended for non-invasive measurement of pulse waveform by photoelectric plethysmography and heart rate by electrocardiograph. The device is for use in outpatient departments of hospitals, healthcare clinics and physician practices.
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    K Number
    K080884
    Device Name
    QHRV 1 - HEALTH ASSESSMENT SYSTEM
    Manufacturer
    MEDTECHS, LLC
    Date Cleared
    2008-04-11

    (11 days)

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

    MEDTECHS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QHRV 1 -- Health Assessment System is intended for (HRV) I leart Rate Variability Measurements in response to a series of paced respiration, standardized and controlled exercises. These measurements and analysis are not intended as clinical diagnosis but only to substantiate appropriate patient health assessment procedures.
    Device Description
    QHRV 1 - Health Assessment System
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