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

    MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER

    K Number: K991001 · Decision Jul 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    12
    Review Days
    112

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    Basic Information

    Device Name
    MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
    K Number
    K991001
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ep Medsystems
    Date Received
    March 25, 1999
    Decision Date
    July 15, 1999
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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    Other Clearances by Ep Medsystems

    K Number Device Name
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    K071028 VIEWMATE SYSTEM
    K070706 EP-WORKMATE
    K063113 EP-WORKMATE
    K041442 EP-4 CLINICAL STIMUTATOR
    K040207 EP-4 CLINICAL STIMULATOR
    K031066 VIEWMATE ULTRASOUND IMAGING SYSTEM
    K032225 EP-WORKMATE WITH RPM SYSTEM
    K984150 PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
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