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

    AESPIRE 7900, AESPIRE VIEW

    K Number: K092864 · Decision Jan 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    117

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    Basic Information

    Device Name
    AESPIRE 7900, AESPIRE VIEW
    K Number
    K092864
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex-Ohmeda Inc., A Division of Instrumentarium C
    Date Received
    September 17, 2009
    Decision Date
    January 12, 2010
    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-Ohmeda Inc., A Division of Instrumentarium C

    K Number Device Name
    K093886 ENGSTROM CARESTATION, ENGSTROM PRO