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

    MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS

    K Number: K073230 · Decision Dec 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    85
    Review Days
    35

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    Basic Information

    Device Name
    MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
    K Number
    K073230
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3720
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotronik, Inc.
    Date Received
    November 15, 2007
    Decision Date
    December 20, 2007
    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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