BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VIEWMATE SYSTEM

    K Number: K071028 · Decision May 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    2
    Applicant Total
    12
    Review Days
    20

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    Basic Information

    Device Name
    VIEWMATE SYSTEM
    K Number
    K071028
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    890.3675
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ep Medsystems
    Date Received
    April 11, 2007
    Decision Date
    May 1, 2007
    Product Code
    ITN
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ITN Splint, Denis Brown

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    K070706 EP-WORKMATE
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    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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