BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    MEDISURF

    K Number: K971347 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    141
    Applicant Total
    5
    Review Days
    84

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    Basic Information

    Device Name
    MEDISURF
    K Number
    K971347
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2020
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Regulatory Consultants
    Date Received
    April 10, 1997
    Decision Date
    July 3, 1997
    Product Code
    LMD
    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
    LMD System, Digital Image Communications, Radiological

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