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

    GALIX ECG PROFESSIONAL STATION

    K Number: K051163 · Decision Jan 31, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    6
    Review Days
    271

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    Basic Information

    Device Name
    GALIX ECG PROFESSIONAL STATION
    K Number
    K051163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Galix Biomedical Instrumentation, Inc.
    Date Received
    May 5, 2005
    Decision Date
    January 31, 2006
    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 Galix Biomedical Instrumentation, Inc.

    K Number Device Name
    K092853 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
    K030145 GALIX WINTER
    K023080 GALIX PACESTAR
    K992706 GALIX GBI -3S-LP
    K971670 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER