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

    MODEL H170 PEDIATRIC CHEST X-RAY UNIT

    K Number: K915667 · Decision Jan 31, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    44

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    Basic Information

    Device Name
    MODEL H170 PEDIATRIC CHEST X-RAY UNIT
    K Number
    K915667
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1880
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    H.L. Lyons Co.
    Date Received
    December 18, 1991
    Decision Date
    January 31, 1992
    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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