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

    LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE

    K Number: K101331 · Decision Oct 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    3
    Review Days
    150

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE
    K Number
    K101331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard Inc., Bard Electrophysiology Division
    Date Received
    May 11, 2010
    Decision Date
    October 8, 2010
    Product Code
    DQK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQK Computer, Diagnostic, Programmable

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DQK), ordered by most recent decision date.

    OneStim-DUO Cardiac Stimulator (MP5003-4CO)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZEUS Platform (FG0501US)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EnSite™ X EP System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACORYS MAPPING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Synchrony

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by C.R. Bard Inc., Bard Electrophysiology Division

    K Number Device Name
    K113811 V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
    K082094 BARD PTFE (TEFLON) COATED GUIDE WIRES