BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇳🇱 Netherlands

    Comfort Marker 2.0.

    K Number: DEN200041 · Decision Dec 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    536

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    Basic Information

    Device Name
    Comfort Marker 2.0.
    K Number
    DEN200041
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.5785
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Medical Precision BV
    Date Received
    June 22, 2020
    Decision Date
    December 10, 2021
    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
    K222112 Comfort Marker 2.0