BEUDAMED
    Product Code: HEL FDA class 2 21 CFR 884.2660

    Monitor, Heart Rate, Fetal, Ultrasonic

    Obstetrics/Gynecology

    The Fetal Ultrasonic Heart Rate Monitor is a device that uses ultrasound (Doppler technology) to detect and display the fetal heart rate, enabling clinicians to assess fetal wellbeing continuously or intermittently during pregnancy or labor. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEL, regulated under 21 CFR 884.2660, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    7
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    6
    Years Active
    23

    Basic Information

    Product Code
    HEL
    Device Class
    FDA class 2
    Regulation Number
    884.2660
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K003876 US SENSOR #CG-930P; TOCO SENSOR CG-940P
    K010920 TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
    K982651 COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
    K971240 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
    K930714 SONICAID MODEL TEAM FECG IUP
    K933816 SONICAID MODEL P110 FETAL HEAR DETECTOR
    K780035 MINIVISOR

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.