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

    MULTIICHALLENGE NEBULIZER SYSTEM

    K Number: K883704 · Decision Nov 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    73
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    MULTIICHALLENGE NEBULIZER SYSTEM
    K Number
    K883704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.6250
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Biotrine Corp.
    Date Received
    August 30, 1988
    Decision Date
    November 28, 1988
    Product Code
    BTI
    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
    BTI Compressor, Air, Portable

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