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

    P2900 X-RAY GENERATOR

    K Number: K921516 · Decision May 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    P2900 X-RAY GENERATOR
    K Number
    K921516
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Precise Optics Photo Medic Equipment, Inc.
    Date Received
    March 31, 1992
    Decision Date
    May 28, 1992
    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 Precise Optics Photo Medic Equipment, Inc.

    K Number Device Name
    K915405 P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)