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

    ROCKET FETAL BLOOD SAMPLING TRAY

    K Number: K884685 · Decision Jan 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    23
    Review Days
    65

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    Basic Information

    Device Name
    ROCKET FETAL BLOOD SAMPLING TRAY
    K Number
    K884685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1560
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    A & A Medical, Inc.
    Date Received
    November 8, 1988
    Decision Date
    January 12, 1989
    Product Code
    HGW
    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
    HGW Sampler, Blood, Fetal

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