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

    TELAMAT

    K Number: K864749 · Decision Feb 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    5
    Review Days
    67

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    Basic Information

    Device Name
    TELAMAT
    K Number
    K864749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Comet Ltd. C/O Radiology Resources, Inc.
    Date Received
    December 5, 1986
    Decision Date
    February 10, 1987
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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

    K Number Device Name
    K912338 TUBE HOUSING ASSEMBLIES
    K911695 VARIOUS X-RAY TUBES
    K910842 DI2000/HS-45-150 X-RAY TUBE INSERT
    K901997 X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS