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

    STEALTHSTATION TREATMENT GUIDANCE PLATFORM

    K Number: K992461 · Decision Feb 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    27
    Review Days
    214

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    Basic Information

    Device Name
    STEALTHSTATION TREATMENT GUIDANCE PLATFORM
    K Number
    K992461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Navigation Technologies, Inc.
    Date Received
    July 23, 1999
    Decision Date
    February 22, 2000
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

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    Other Clearances by Surgical Navigation Technologies, Inc.

    K Number Device Name
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    K993021 METRX SYSTEM
    K992354 SNT IMAGE ANALYSIS SYSTEM
    K991468 IMMERGE IMAGE CORRELATION
    K990214 FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
    K983670 STEALTHSTATION SYSTEM
    K984000 STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
    K983397 STEALTHSTATION TREATMENT GUIDANCE PLAFFORM
    Search all 27 clearances from Surgical Navigation Technologies, Inc. →