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

    COMBITRANS MONITORING SETS AND ACCESSORIES

    K Number: K102033 · Decision Apr 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    5
    Review Days
    262

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    Basic Information

    Device Name
    COMBITRANS MONITORING SETS AND ACCESSORIES
    K Number
    K102033
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.Braun Melsungen AG
    Date Received
    July 19, 2010
    Decision Date
    April 7, 2011
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

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    Other Clearances by B.Braun Melsungen AG

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    K111236 INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1