BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PORTABLE BREAST COMPRESSION DEVICE

    K Number: K003775 · Decision Jan 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    129
    Applicant Total
    2
    Review Days
    37

    Basic Information

    Device Name
    PORTABLE BREAST COMPRESSION DEVICE
    K Number
    K003775
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PEM TECHNOLOGIES
    Date Received
    December 6, 2000
    Decision Date
    January 12, 2001
    Product Code
    IYX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYX Camera, Scintillation (Gamma)

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