BEUDAMED
    Product Code: HEI FDA class 2 21 CFR 884.2660

    Monitor, Heart-Valve Movement, Fetal, Ultrasonic

    Obstetrics/Gynecology

    The Fetal Ultrasonic Heart-Valve Movement Monitor is a device that uses ultrasound to detect and monitor the movement of fetal heart valves, providing information on fetal cardiac activity during pregnancy. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEI, 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
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    10

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    Basic Information

    Product Code
    HEI
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K012003 DRG REACTION CHAMBER/SAFETY TIP
    K920985 SNOWDEN-PENCER IRRIGATION PUMP
    K910982 INNERVISION IRRIGATION PUMP