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

    SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000

    K Number: K003458 · Decision May 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    16
    Applicant Total
    9
    Review Days
    177

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    Basic Information

    Device Name
    SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
    K Number
    K003458
    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
    November 7, 2000
    Decision Date
    May 3, 2001
    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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    Other Clearances by Clinical Innovations, Inc.

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    K974563 COLPO CUP CVC-2000
    K974389 KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
    K973746 PRE-FILLED SYRINGE FOR KOALA IUP
    K954955 STORC INTRAUTERINE PRESSURE CATHETER
    K940681 CLEARVIEW UTERINE MANIPULATOR