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

    VOYAGR SERIES DIAGNOSTIC EP CATHETERS

    K Number: K923916 · Decision Feb 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    2
    Review Days
    197

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    Basic Information

    Device Name
    VOYAGR SERIES DIAGNOSTIC EP CATHETERS
    K Number
    K923916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardiorhythm
    Date Received
    July 28, 1992
    Decision Date
    February 10, 1993
    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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