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

    LADD MEDICAL S-2000

    K Number: K862012 · Decision Jun 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    3
    Review Days
    12

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    Basic Information

    Device Name
    LADD MEDICAL S-2000
    K Number
    K862012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Ladd Research Industries, Inc.
    Date Received
    May 28, 1986
    Decision Date
    June 9, 1986
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWM Device, Monitoring, Intracranial Pressure

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    Other Clearances by Ladd Research Industries, Inc.

    K Number Device Name
    K893395 MINI-MONITOR J7000 ICP
    K862820 LADD/STERITEK ICP MONITOR, CAT. NO. P3000