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

    3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

    K Number: K092853 · Decision Jul 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    296

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    Basic Information

    Device Name
    3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
    K Number
    K092853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Galix Biomedical Instrumentation, Inc.
    Date Received
    September 16, 2009
    Decision Date
    July 9, 2010
    Product Code
    MLO
    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
    MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

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    Other Clearances by Galix Biomedical Instrumentation, Inc.

    K Number Device Name
    K051163 GALIX ECG PROFESSIONAL STATION
    K030145 GALIX WINTER
    K023080 GALIX PACESTAR
    K992706 GALIX GBI -3S-LP
    K971670 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER