BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Spinal Manometer NRFit; Spinal Manometer LUER

    K Number: K170305 · Decision Jul 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    44
    Review Days
    175

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    Basic Information

    Device Name
    Spinal Manometer NRFit; Spinal Manometer LUER
    K Number
    K170305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PAJUNK GmbH Medizintechnologie
    Date Received
    January 31, 2017
    Decision Date
    July 25, 2017
    Product Code
    FMJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMJ Manometer, Spinal-Fluid

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