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

    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

    K Number: K040392 · Decision Sep 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    22
    Applicant Total
    7
    Review Days
    210

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    Basic Information

    Device Name
    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    K Number
    K040392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American I.V. Products, Inc.
    Date Received
    February 17, 2004
    Decision Date
    September 14, 2004
    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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    Other Clearances by American I.V. Products, Inc.

    K Number Device Name
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    K070232 ECG CABLES, TRUNK AND PATIENT LEAD WIRES
    K070342 CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
    K052544 PULSE OXIMETER ADAPTER CABLES
    K040819 TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
    K032789 REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469