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

    EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04

    K Number: K092913 · Decision Oct 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    17
    Applicant Total
    12
    Review Days
    24

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    Basic Information

    Device Name
    EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
    K Number
    K092913
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1750
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ep Medsystems
    Date Received
    September 22, 2009
    Decision Date
    October 16, 2009
    Product Code
    JOQ
    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
    JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

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    Other Clearances by Ep Medsystems

    K Number Device Name
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    K063113 EP-WORKMATE
    K041442 EP-4 CLINICAL STIMUTATOR
    K040207 EP-4 CLINICAL STIMULATOR
    K031066 VIEWMATE ULTRASOUND IMAGING SYSTEM
    K032225 EP-WORKMATE WITH RPM SYSTEM
    K991001 MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
    K984150 PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
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