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

    GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)

    K Number: K102905 · Decision Oct 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    3
    Review Days
    29

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    Basic Information

    Device Name
    GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)
    K Number
    K102905
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mediguide, Ltd.
    Date Received
    September 30, 2010
    Decision Date
    October 29, 2010
    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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    Other Clearances by Mediguide, Ltd.

    K Number Device Name
    K091781 GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
    K091780 GUIDED MEASUREMENT CATHETER (GMC)