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

    PHILIPS HERCEPTEST DIGITAL SCORE

    K Number: K130021 · Decision Sep 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    104
    Review Days
    259

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    Basic Information

    Device Name
    PHILIPS HERCEPTEST DIGITAL SCORE
    K Number
    K130021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems Nederland B.V.
    Date Received
    January 3, 2013
    Decision Date
    September 19, 2013
    Product Code
    OEO
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OEO Automated Digital Image Manual Interpretation Microscope

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