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

    FETAL SCALP SPIRAL ELECTRODE

    K Number: K911657 · Decision Jul 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    16
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    FETAL SCALP SPIRAL ELECTRODE
    K Number
    K911657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2675
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Medical Systems, Inc.
    Date Received
    April 12, 1991
    Decision Date
    July 11, 1991
    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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    K894568 NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
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