BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇸🇪 Sweden

    OLINDA EXM

    K Number: K163687 · Decision Jul 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    129
    Applicant Total
    9
    Review Days
    203

    Basic Information

    Device Name
    OLINDA EXM
    K Number
    K163687
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hermes Medical Solutions AB
    Date Received
    December 28, 2016
    Decision Date
    July 19, 2017
    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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