BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)

    K Number: K951004 · Decision Apr 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    24
    Applicant Total
    4
    Review Days
    54

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    Basic Information

    Device Name
    2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
    K Number
    K951004
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kenex , Ltd.
    Date Received
    February 15, 1995
    Decision Date
    April 10, 1995
    Product Code
    KPY
    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
    KPY Shield, Protective, Personnel

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