BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPACEMISER 8-17 FILM RECORDER

    K Number: K871958 · Decision Jun 22, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    5
    Review Days
    33

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    Basic Information

    Device Name
    SPACEMISER 8-17 FILM RECORDER
    K Number
    K871958
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Frantz Imaging, Inc.
    Date Received
    May 20, 1987
    Decision Date
    June 22, 1987
    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 Frantz Imaging, Inc.

    K Number Device Name
    K952485 LASERNET IMAGE MANAGER/PRINT SERVER
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    K871959 FRANTZ IMAGING COMPACT CAMERA