BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LUMBAR PUNCTURE KIT

    K Number: K970287 · Decision Apr 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    149
    Review Days
    73

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    Basic Information

    Device Name
    LUMBAR PUNCTURE KIT
    K Number
    K970287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.Braun Medical, Inc.
    Date Received
    January 24, 1997
    Decision Date
    April 7, 1997
    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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