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510(k) Data Aggregation

    K Number
    K001866
    Device Name
    TCM400
    Manufacturer
    RADIOMETER MEDICAL A/S
    Date Cleared
    2000-12-07

    (170 days)

    Product Code
    LPP
    Regulation Number
    868.2500
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002290
    Device Name
    ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
    Manufacturer
    RADIOMETER MEDICAL A/S
    Date Cleared
    2000-09-13

    (48 days)

    Product Code
    CHL, CEM, CGA, CGZ, CIG, GKF, JFP, JGS, KHP
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER MEDICAL A/S

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

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