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

    DEVILBISS 9000 SERIES CPAP, MODEL 9001

    K Number: K011229 · Decision Jul 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    10
    Review Days
    79

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    Basic Information

    Device Name
    DEVILBISS 9000 SERIES CPAP, MODEL 9001
    K Number
    K011229
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunrise Medical Hhg, Inc.
    Date Received
    April 23, 2001
    Decision Date
    July 11, 2001
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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