BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.

    K Number: K803032 · Decision Jan 22, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    69
    Applicant Total
    12
    Review Days
    52

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    Basic Information

    Device Name
    PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.
    K Number
    K803032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Pfizer Medical Systems, Inc.
    Date Received
    December 1, 1980
    Decision Date
    January 22, 1981
    Product Code
    KPQ
    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
    KPQ System, Simulation, Radiation Therapy

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