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510(k) Data Aggregation

    K Number
    K063277
    Device Name
    MAPMATE
    Manufacturer
    EP MEDSYSTEMS, INC.
    Date Cleared
    2006-11-30

    (30 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    EP MEDSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MapMate™ is indicated for use during clinical electrophysiology procedures.
    Device Description
    This application describes a modification to the EP-WorkMate® system that will be offered as an option to customers under the name MapMate™. MapMate™ is comprised of a software module and an electronic interconnection between the EPMedSystems EP-WorkMate® and the BioSense Webster CARTO™ XP Navigation System computer. When the MapMate™ option is utilized, clinicians enter patient data in one system instead of two. A procedure log is created containing the list of map points along with the EP signals. Therefore, valuable time and attention are conserved in the busy EP lab enabling clinicians to focus on the EP case.
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    K Number
    K033963
    Device Name
    EP DEFLECTABLE CATHETERS
    Manufacturer
    EP MEDSYSTEMS, INC.
    Date Cleared
    2004-04-15

    (115 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    EP MEDSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.
    Device Description
    EP Deflectable Catheters
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    K Number
    K994011
    Device Name
    EP MEDSYSTEMS, EP-WORKMATE
    Manufacturer
    EP MEDSYSTEMS, INC.
    Date Cleared
    2000-03-23

    (118 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    EP MEDSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EP-WorkMate® Computerized Electrophysiology Recording System is intended for use during clinical electrophysiology procedures.
    Device Description
    Not Found
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