BEUDAMED
    Product Code: HER FDA class 1 21 CFR 884.4520

    Pelvimeter, External

    Obstetrics/Gynecology

    The External Pelvimeter is a manual measurement instrument used to assess the dimensions of the external bony pelvis, particularly in pregnant patients, to evaluate the likelihood of successful vaginal delivery. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HER, regulated under 21 CFR 884.4520, within the Obstetrics/Gynecology specialty. No special risk flags apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    28
    Registration Numbers
    28
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HER
    Device Class
    FDA class 1
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.