BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Foresight Intracardiac Echocardiology (ICE) System

    K Number: K162789 · Decision Mar 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    497
    Applicant Total
    2
    Review Days
    175

    Basic Information

    Device Name
    Foresight Intracardiac Echocardiology (ICE) System
    K Number
    K162789
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conavi Medical Inc.
    Date Received
    October 4, 2016
    Decision Date
    March 28, 2017
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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