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

    FETAL SPIRAL ELECTRODE, MODEL FSE07000

    K Number: K030691 · Decision Sep 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    16
    Applicant Total
    9
    Review Days
    196

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    Basic Information

    Device Name
    FETAL SPIRAL ELECTRODE, MODEL FSE07000
    K Number
    K030691
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2675
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Innovations, Inc.
    Date Received
    March 5, 2003
    Decision Date
    September 17, 2003
    Product Code
    HGP
    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
    HGP Electrode, Circular (Spiral), Scalp And Applicator

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