BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PB-A LEAD-ACID BATTERY CONVERSION KIT

    K Number: K875106 · Decision Feb 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    223
    Applicant Total
    2
    Review Days
    70

    Basic Information

    Device Name
    PB-A LEAD-ACID BATTERY CONVERSION KIT
    K Number
    K875106
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    DIAGNOSTIC IMAGING SPECIALISTS CORP.
    Date Received
    December 14, 1987
    Decision Date
    February 22, 1988
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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