BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NEBU-SOL METERED DOSE DISPENSER (TM)

    K Number: K910239 · Decision May 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    115
    Applicant Total
    6
    Review Days
    120

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    Basic Information

    Device Name
    NEBU-SOL METERED DOSE DISPENSER (TM)
    K Number
    K910239
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Dey Laboratories, Inc.
    Date Received
    January 22, 1991
    Decision Date
    May 22, 1991
    Product Code
    BSY
    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
    BSY Catheters, Suction, Tracheobronchial

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