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

    CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM

    K Number: K935979 · Decision Nov 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    29
    Review Days
    332

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    Basic Information

    Device Name
    CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM
    K Number
    K935979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Devilbiss Health Care, Inc.
    Date Received
    December 13, 1993
    Decision Date
    November 10, 1994
    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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