BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇭 Switzerland

    TUBE HOUSING ASSEMBLIES

    K Number: K912338 · Decision Aug 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    39
    Applicant Total
    5
    Review Days
    75

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    Basic Information

    Device Name
    TUBE HOUSING ASSEMBLIES
    K Number
    K912338
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1760
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Comet Ltd. C/O Radiology Resources, Inc.
    Date Received
    May 24, 1991
    Decision Date
    August 7, 1991
    Product Code
    ITY
    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
    ITY Assembly, Tube Housing, X-Ray, Diagnostic

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    Other Clearances by Comet Ltd. C/O Radiology Resources, Inc.

    K Number Device Name
    K911695 VARIOUS X-RAY TUBES
    K910842 DI2000/HS-45-150 X-RAY TUBE INSERT
    K901997 X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
    K864749 TELAMAT