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510(k) Data Aggregation

    K Number
    K003257

    Validate with FDA (Live)

    Device Name
    EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION
    Manufacturer
    CYBERCARE TECHNOLOGIES, INC.
    Date Cleared
    2000-12-22

    (65 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K020534
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K002984

    Validate with FDA (Live)

    Device Name
    EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION
    Manufacturer
    CYBERCARE TECHNOLOGIES, INC.
    Date Cleared
    2000-12-18

    (84 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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