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

    MODEL 4810 ANALYZER OUTPUT ADAPTER

    K Number: K002497 · Decision Oct 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    29
    Applicant Total
    19
    Review Days
    57

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    Basic Information

    Device Name
    MODEL 4810 ANALYZER OUTPUT ADAPTER
    K Number
    K002497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3630
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pace Medical
    Date Received
    August 14, 2000
    Decision Date
    October 10, 2000
    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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    Other Clearances by Pace Medical

    K Number Device Name
    K011980 ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
    K012392 DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
    K002204 PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
    K002496 MODEL 4815 ADAPTER
    K001180 TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
    K925143 MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
    K931662 LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
    K922899 MODEL 4280 SURGICAL EXTENSION CABLE
    K913805 MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
    K913134 MODEL 4220
    Search all 19 clearances from Pace Medical →