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

    PMT SUBDURAL CORTICAL ELECTRODES

    K Number: K082474 · Decision May 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    31
    Applicant Total
    20
    Review Days
    253

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    Basic Information

    Device Name
    PMT SUBDURAL CORTICAL ELECTRODES
    K Number
    K082474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pmt Corp.
    Date Received
    August 28, 2008
    Decision Date
    May 8, 2009
    Product Code
    GYC
    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
    GYC Electrode, Cortical

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    Other Clearances by Pmt Corp.

    K Number Device Name
    K122376 PMT TRUSCAN SURFACE ELECTRODE
    K090733 PMT HALO SYSTEM
    K042901 ENDOMARK STERILE INDIA INK
    K033730 PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
    K972597 PMT NEW BEGINNINGS GELSHAPES & AMEND
    K970418 PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
    K964224 STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE
    K935560 PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)
    K933079 ELECTROCAUTERY SYSTEM MODEL 1980
    K935499 PMT SILICONE SHEETING
    Search all 20 clearances from Pmt Corp. →