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

    SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE

    K Number: K970170 · Decision Mar 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    78

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    Basic Information

    Device Name
    SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
    K Number
    K970170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4340
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard G. Lindsay
    Date Received
    January 9, 1997
    Decision Date
    March 28, 1997
    Product Code
    HDB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HDB Extractor, Vacuum, Fetal

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