BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Comfort Marker 2.0

    K Number: K222112 · Decision Mar 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    255

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    Basic Information

    Device Name
    Comfort Marker 2.0
    K Number
    K222112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5785
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Precision BV
    Date Received
    July 18, 2022
    Decision Date
    March 30, 2023
    Product Code
    QRN
    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
    QRN Radiation Therapy Marking Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QRN), ordered by most recent decision date.

    Comfort Marker 2.0.

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Medical Precision BV

    K Number Device Name
    DEN200041 Comfort Marker 2.0.