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

    ADAPTER CABLE

    K Number: K050884 · Decision May 19, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    19
    Review Days
    42

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    Basic Information

    Device Name
    ADAPTER CABLE
    K Number
    K050884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3720
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remington Medical, Inc.
    Date Received
    April 7, 2005
    Decision Date
    May 19, 2005
    Product Code
    DTA
    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
    DTA Tester, Pacemaker Electrode Function

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