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

    CENTRALITE(R)-DLL SERIES

    K Number: K950112 · Decision Aug 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    27
    Applicant Total
    10
    Review Days
    217

    Basic Information

    Device Name
    CENTRALITE(R)-DLL SERIES
    K Number
    K950112
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5780
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DIACOR, INC.
    Date Received
    January 11, 1995
    Decision Date
    August 16, 1995
    Product Code
    IWE
    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
    IWE Monitor, Patient Position, Light-Beam

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