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

    COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM

    K Number: K083413 · Decision Dec 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    107
    Review Days
    30

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    Basic Information

    Device Name
    COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
    K Number
    K083413
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems
    Date Received
    November 18, 2008
    Decision Date
    December 18, 2008
    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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