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

    MICROAIRE 1000E SYSTEM

    K Number: K014060 · Decision Mar 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    4
    Review Days
    85

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    Basic Information

    Device Name
    MICROAIRE 1000E SYSTEM
    K Number
    K014060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microaire Surgical Instruments, Inc.
    Date Received
    December 10, 2001
    Decision Date
    March 5, 2002
    Product Code
    HBE
    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
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

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    Other Clearances by Microaire Surgical Instruments, Inc.

    K Number Device Name
    K981922 LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
    K973268 MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM
    K955591 MICROAIRE SMARTDRIVE SYSTEM