BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM

    K Number: K972314 · Decision Dec 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    4
    Review Days
    182

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    Basic Information

    Device Name
    PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
    K Number
    K972314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diametrics Medical, Ltd.
    Date Received
    June 20, 1997
    Decision Date
    December 19, 1997
    Product Code
    CCC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

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    Other Clearances by Diametrics Medical, Ltd.

    K Number Device Name
    K983198 TRENDCARE CALIBRATOR MODEL SCU 7007
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    K970906 PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR