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

    THE ROBOLITE

    K Number: K964460 · Decision Jan 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    77
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    THE ROBOLITE
    K Number
    K964460
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shai Syg Motion and Innovations, Ltd.
    Date Received
    November 7, 1996
    Decision Date
    January 24, 1997
    Product Code
    JQP
    Advisory Committee
    Clinical Chemistry
    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
    JQP Calculator/Data Processing Module, For Clinical Use

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    Other Clearances by Shai Syg Motion and Innovations, Ltd.

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