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

    MIDMARK IQECG

    K Number: K103640 · Decision Mar 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    7
    Review Days
    99

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    Basic Information

    Device Name
    MIDMARK IQECG
    K Number
    K103640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brentwood Medical Technology Corp.
    Date Received
    December 13, 2010
    Decision Date
    March 22, 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 Brentwood Medical Technology Corp.

    K Number Device Name
    K100913 IQVITALS AND IQVITALS SYSTEM
    K052898 IQMARK EZ STRESS
    K031466 IQMARK DIGITAL HOLTER
    K013717 BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
    K010505 TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
    K002499 BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE