BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    COLORPOINT OR PROFESSIONAL COLORPOINT

    K Number: K971760 · Decision Oct 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    2
    Review Days
    142

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    Basic Information

    Device Name
    COLORPOINT OR PROFESSIONAL COLORPOINT
    K Number
    K971760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Seiko Instruments USA, Inc.
    Date Received
    May 12, 1997
    Decision Date
    October 1, 1997
    Product Code
    LMC
    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
    LMC Camera, Multi Format, Radiological

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    Other Clearances by Seiko Instruments USA, Inc.

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