BEUDAMED
    Product Code: HEJ FDA class 2 21 CFR 884.2660

    Monitor, Hemic Sound, Ultrasonic

    Obstetrics/Gynecology

    The Ultrasonic Hemic Sound Monitor is a device using ultrasound technology to detect and monitor blood flow sounds in obstetric and gynecological contexts, providing non-invasive assessment of circulatory activity. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEJ, regulated under 21 CFR 884.2660, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HEJ
    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
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    Summary Malfunction Reporting