BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

    K Number: K994175 · Decision Dec 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    11

    Basic Information

    Device Name
    MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
    K Number
    K994175
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4370
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SODEM SYSTEMS
    Date Received
    December 10, 1999
    Decision Date
    December 21, 1999
    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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    Other Clearances by SODEM SYSTEMS

    K Number Device Name
    K023070 SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K023066 DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K012457 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
    K012453 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
    K012456 SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)