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

    FLOW GENERATOR FOR SLEEP APNEA, LDS 1500

    K Number: K862448 · Decision Nov 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    29
    Review Days
    140

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    Basic Information

    Device Name
    FLOW GENERATOR FOR SLEEP APNEA, LDS 1500
    K Number
    K862448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Life Design Systems, Inc.
    Date Received
    June 27, 1986
    Decision Date
    November 14, 1986
    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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