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510(k) Data Aggregation

    K Number
    K021605
    Device Name
    MEDGEM
    Manufacturer
    HEALTHETECH, INC.
    Date Cleared
    2002-06-14

    (29 days)

    Product Code
    BZL
    Regulation Number
    868.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHETECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedGem is intended for use in clinical and research applications to measure oxygen uptake.
    Device Description
    Not Found
    Ask a Question
    K Number
    K010577
    Device Name
    BODYGEM, MODEL HB211
    Manufacturer
    HEALTHETECH, INC.
    Date Cleared
    2002-01-10

    (317 days)

    Product Code
    BZL
    Regulation Number
    868.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHETECH, INC.

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

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