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

    FEATHERLITE AQUA TOCODYNAMOMETER

    K Number: K061044 · Decision Jul 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    FEATHERLITE AQUA TOCODYNAMOMETER
    K Number
    K061044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ventrex, Inc.
    Date Received
    April 14, 2006
    Decision Date
    July 12, 2006
    Product Code
    HFM
    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
    HFM Monitor, Uterine Contraction, External (For Use In Clinic)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HFM), ordered by most recent decision date.

    KOALA TOCO

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    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

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    TOCO LITE, MODEL TD-01

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    SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565

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    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

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    FDA Class 2 ·Obstetrics/Gynecology

    DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES

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    FDA Class 2 ·Obstetrics/Gynecology
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    Other Clearances by Ventrex, Inc.

    K Number Device Name
    K013477 TOCO LITE, MODEL TD-01
    K964821 COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
    K925044 VENTREX ALLERGEN DISC
    K924119 VENTREX ALLERGEN DISC