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

    ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS

    K Number: K133604 · Decision Jan 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    25
    Applicant Total
    60
    Review Days
    46

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    Basic Information

    Device Name
    ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
    K Number
    K133604
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4360
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Anspach Effort, Inc.
    Date Received
    November 25, 2013
    Decision Date
    January 10, 2014
    Product Code
    HBC
    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
    HBC Motor, Drill, Electric

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