BEUDAMED
    Product Code: KXN FDA class 2 21 CFR 884.2600

    Monitor, Cardiac, Fetal

    Obstetrics/Gynecology

    The Fetal Cardiac Monitor is a device used during pregnancy and labor to continuously or intermittently record and display the fetal heart rate, enabling clinicians to detect signs of fetal distress and assess fetal well-being. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXN, regulated under 21 CFR 884.2600, in the Obstetrics/Gynecology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    0

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    Basic Information

    Product Code
    KXN
    Device Class
    FDA class 2
    Regulation Number
    884.2600
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K770245 ABDOMINAL FETAL ECG MODULE
    K760968 CENTRAL STATION REPEATER (MODEL 8032A)