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

    MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

    K Number: K033613 · Decision Dec 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    85
    Review Days
    21

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    Basic Information

    Device Name
    MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
    K Number
    K033613
    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 17, 2003
    Decision Date
    December 8, 2003
    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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