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

    Reprocessed Response Diagnostic Electrophysiology Catheters

    K Number: K161827 · Decision Dec 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    69
    Applicant Total
    48
    Review Days
    156

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    Basic Information

    Device Name
    Reprocessed Response Diagnostic Electrophysiology Catheters
    K Number
    K161827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Health, LLC
    Date Received
    July 5, 2016
    Decision Date
    December 8, 2016
    Product Code
    NLH
    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
    NLH Catheter, Recording, Electrode, Reprocessed

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