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

    NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

    K Number: K031885 · Decision Aug 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    22
    Review Days
    64

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    Basic Information

    Device Name
    NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
    K Number
    K031885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Image-Guided Neurologics, Inc.
    Date Received
    June 18, 2003
    Decision Date
    August 21, 2003
    Product Code
    HBL
    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
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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