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

    MOBILEECG SYSTEM

    K Number: K103427 · Decision Mar 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    3
    Review Days
    122

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    Basic Information

    Device Name
    MOBILEECG SYSTEM
    K Number
    K103427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Memtec Corp.
    Date Received
    November 22, 2010
    Decision Date
    March 24, 2011
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Memtec Corp.

    K Number Device Name
    K102723 MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
    K944180 MODEL 700