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

    PMT HALO SYSTEM

    K Number: K090733 · Decision Jul 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    20
    Review Days
    131

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    Basic Information

    Device Name
    PMT HALO SYSTEM
    K Number
    K090733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pmt Corp.
    Date Received
    March 19, 2009
    Decision Date
    July 28, 2009
    Product Code
    HAX
    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
    HAX Tong, Skull For Traction

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    Other Clearances by Pmt Corp.

    K Number Device Name
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    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. →