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510(k) Data Aggregation

    K Number
    K011779
    Device Name
    AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
    Manufacturer
    AVID CARE CORP.
    Date Cleared
    2001-07-13

    (36 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVID CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for both the cleared and the modified Home Health Monitor System is for home use, patient operated: - 1. non-invasive blood pressure measurement. - 2. non-invasive blood oxygen saturation measurement using pulse oximetry, - 3. in vitro diagnostic quantitative measurement of glucose in fresh capillary whole blood, and - 4. patient weight using a stand-on electronic scale; and subsequent transmission of these measurements to a computer monitoring station in a clinical setting.
    Device Description
    Home Health Monitor System
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    K Number
    K010029
    Device Name
    HOME HEALTH MONITORING SYSTEM
    Manufacturer
    AVID CARE CORP.
    Date Cleared
    2001-06-29

    (177 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVID CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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