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

    PK-141 PATIENT CABLE

    K Number: K083674 · Decision Apr 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    29
    Applicant Total
    85
    Review Days
    111

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    Basic Information

    Device Name
    PK-141 PATIENT CABLE
    K Number
    K083674
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3630
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotronik, Inc.
    Date Received
    December 11, 2008
    Decision Date
    April 1, 2009
    Product Code
    DTC
    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
    DTC Analyzer, Pacemaker Generator Function

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