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

    NTBS-1417, 1436, TBS-1417

    K Number: K946260 · Decision Mar 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    20
    Applicant Total
    7
    Review Days
    108

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    Basic Information

    Device Name
    NTBS-1417, 1436, TBS-1417
    K Number
    K946260
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1880
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scott Imaging Intl., Inc.
    Date Received
    December 13, 1994
    Decision Date
    March 31, 1995
    Product Code
    IXY
    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
    IXY Holder, Radiographic Cassette, Wall-Mounted

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