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

    MARS HOLTER ANALYSIS WORKSTATION

    K Number: K093141 · Decision Dec 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    136
    Review Days
    85

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    Basic Information

    Device Name
    MARS HOLTER ANALYSIS WORKSTATION
    K Number
    K093141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    October 5, 2009
    Decision Date
    December 29, 2009
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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