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510(k) Data Aggregation

    K Number
    K003257
    Date Cleared
    2000-12-22

    (65 days)

    Product Code
    Regulation Number
    862.1345
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K002984
    Date Cleared
    2000-12-18

    (84 days)

    Product Code
    Regulation Number
    870.1875
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION

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

    Ask a specific question about this device

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