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

    HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR

    K Number: K851011 · Decision Apr 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR
    K Number
    K851011
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Hofmann X-Ray of America, Inc.
    Date Received
    March 12, 1985
    Decision Date
    April 10, 1985
    Product Code
    IZO
    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
    IZO Generator, High-Voltage, X-Ray, Diagnostic

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    Other Clearances by Hofmann X-Ray of America, Inc.

    K Number Device Name
    K893690 SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)