BEUDAMED
    Product Code: MPU FDA class 2 21 CFR 884.4530

    Source, Chemiluminescent Light

    Obstetrics/Gynecology

    The Chemiluminescent Light Source is an obstetrics/gynecology device that provides non-electrical, chemically generated illumination used in conjunction with salpingoscopy or other gynecological procedures where a portable, flameless light source is needed. Classified as FDA Class 2 under 21 CFR 884.4530, it requires 510(k) premarket notification. The product code is MPU.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    4

    Research product code MPU in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    MPU
    Device Class
    FDA class 2
    Regulation Number
    884.4530
    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

    Loading...

    Related 510(k) Clearances

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

    K Number Device Name
    K012070 ORALLITE COMPREHENSIVE EXAM TRAY
    K963391 SPECULITE