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

    V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

    K Number: K113811 · Decision Mar 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    3
    Review Days
    84

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    Basic Information

    Device Name
    V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
    K Number
    K113811
    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
    December 23, 2011
    Decision Date
    March 16, 2012
    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

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

    K Number Device Name
    K101331 LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE
    K082094 BARD PTFE (TEFLON) COATED GUIDE WIRES