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

    (SPAG) MODEL SPAG-2 6000 SERIES

    K Number: K871427 · Decision Oct 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    5
    Review Days
    180

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    Basic Information

    Device Name
    (SPAG) MODEL SPAG-2 6000 SERIES
    K Number
    K871427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Viratek, Inc.
    Date Received
    April 9, 1987
    Decision Date
    October 6, 1987
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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