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

    ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA

    K Number: K052335 · Decision Nov 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
    K Number
    K052335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accutron, Inc.
    Date Received
    August 26, 2005
    Decision Date
    November 23, 2005
    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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