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

    ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM

    K Number: K061297 · Decision Jan 26, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    26
    Applicant Total
    60
    Review Days
    262

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    Basic Information

    Device Name
    ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
    K Number
    K061297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4370
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Anspach Effort, Inc.
    Date Received
    May 9, 2006
    Decision Date
    January 26, 2007
    Product Code
    HBB
    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
    HBB Motor, Drill, Pneumatic

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