BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    QUANTITATIVE SENTINEL SYSTEM

    K Number: K963608 · Decision Mar 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    8
    Review Days
    182

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    Basic Information

    Device Name
    QUANTITATIVE SENTINEL SYSTEM
    K Number
    K963608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantitative Medicine, Inc.
    Date Received
    September 10, 1996
    Decision Date
    March 11, 1997
    Product Code
    HGM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HGM System, Monitoring, Perinatal

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    K Number Device Name
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    K912463 MICRO-Q
    K904603 QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
    K833395 SENTINEL SYSTEMS