BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    VPW2877E7 X RAY POWER SUPPLY

    K Number: K905855 · Decision Feb 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    7
    Review Days
    54

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    Basic Information

    Device Name
    VPW2877E7 X RAY POWER SUPPLY
    K Number
    K905855
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Varian Canada, Inc.
    Date Received
    December 21, 1990
    Decision Date
    February 13, 1991
    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 Varian Canada, Inc.

    K Number Device Name
    K953582 HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
    K923455 HFG 350, 650, 1050
    K920938 VJW2919 PNEUMATIC COMPRESSION UPGRADE
    K913234 VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
    K910820 VPW 2877E6 X-RAY POWER SUPPLY
    K904169 VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY