BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    DATEX AS/3 TM ANAESTHESIA MONITOR

    K Number: K933285 · Decision Nov 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    55
    Review Days
    496

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    Basic Information

    Device Name
    DATEX AS/3 TM ANAESTHESIA MONITOR
    K Number
    K933285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex Division Instrumentarium Corp.
    Date Received
    July 6, 1993
    Decision Date
    November 14, 1994
    Product Code
    BSZ
    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
    BSZ Gas-Machine, Anesthesia

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    Other Clearances by Datex Division Instrumentarium Corp.

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