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

    CHARTR ENG SYSTEM

    K Number: K931609 · Decision Sep 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    10
    Review Days
    908

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    Basic Information

    Device Name
    CHARTR ENG SYSTEM
    K Number
    K931609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ics Medical Corp.
    Date Received
    April 1, 1993
    Decision Date
    September 26, 1995
    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 Ics Medical Corp.

    K Number Device Name
    K011181 ICS MEDICAL CHARTR OAE WITH TYMP
    K002985 ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
    K991497 ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
    K972631 ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
    K960097 CHARTR EP
    K931608 NCA-200
    K925237 AUTOMATIC CALORIC IRRIGATION SYSTEM
    K881630 AUTOMATIC CALORIC IRRIGATION SYSTEM
    K872093 RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING