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

    RectalPro 75 Endorectal Balloon

    K Number: K180478 · Decision Nov 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    RectalPro 75 Endorectal Balloon
    K Number
    K180478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qlrad International , Ltd.
    Date Received
    February 22, 2018
    Decision Date
    November 13, 2018
    Product Code
    PCT
    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
    PCT Prostate Immobilizer Rectal Balloon

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