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

    JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100

    K Number: K963334 · Decision Sep 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    16

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    Basic Information

    Device Name
    JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
    K Number
    K963334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jamieson Film Co.
    Date Received
    August 26, 1996
    Decision Date
    September 11, 1996
    Product Code
    IXX
    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
    IXX Processor, Cine Film

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    Other Clearances by Jamieson Film Co.

    K Number Device Name
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    K960043 KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM
    K953563 VANGUARD XR-350 CINEANGIOGRAM PROJECTOR
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