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

    PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR

    K Number: K970906 · Decision Sep 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    4
    Review Days
    195

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    Basic Information

    Device Name
    PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR
    K Number
    K970906
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1170
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diametrics Medical, Ltd.
    Date Received
    March 12, 1997
    Decision Date
    September 23, 1997
    Product Code
    CBZ
    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
    CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

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    Other Clearances by Diametrics Medical, Ltd.

    K Number Device Name
    K983198 TRENDCARE CALIBRATOR MODEL SCU 7007
    K980380 NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
    K972314 PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM