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

    SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT

    K Number: K827346 · Decision Feb 14, 1983
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    54

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT
    K Number
    K827346
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Rayflow Italia S.R.L.
    Date Received
    December 22, 1982
    Decision Date
    February 14, 1983
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N