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

    ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM

    K Number: K070710 · Decision Apr 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
    K Number
    K070710
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosensors International-USA
    Date Received
    March 14, 2007
    Decision Date
    April 19, 2007
    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 Biosensors International-USA

    K Number Device Name
    K022004 CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1