BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL ALPHA TS-2

    K Number: K935004 · Decision Dec 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    55

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    Basic Information

    Device Name
    MODEL ALPHA TS-2
    K Number
    K935004
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dpa Consulting, Inc.
    Date Received
    October 19, 1993
    Decision Date
    December 13, 1993
    Product Code
    IYB
    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
    IYB Tube Mount, X-Ray, Diagnostic

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