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

    AIR-CUSHION TOCOTONOMETER

    K Number: K860933 · Decision Jul 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    119

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    Basic Information

    Device Name
    AIR-CUSHION TOCOTONOMETER
    K Number
    K860933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    International Biomedics, Inc.
    Date Received
    March 12, 1986
    Decision Date
    July 9, 1986
    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)

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    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

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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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    Other Clearances by International Biomedics, Inc.

    K Number Device Name
    K031096 MODIFICATION TO TRANSPORT INCUBATOR 185
    K862072 FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
    K860295 FETASCAN 1500
    K852439 FETA SCAN 1000 OBSTETRICAL IMAGER